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An Emerging Paradigm Change in the Treatment of Multiple Diseases
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Recent News & Events

Jan

28

Marc Y. Donath MD Renowned Immuno-Endocrinologist Appointed to Olatec's Clinical Advisory Board​
NEW YORK--(BUSINESS WIRE)--Olatec Therapeutics, Inc., a leader in the developing class of selective NLRP3 inhibitors, today announced that long-time collaborator and advisor, Prof. Dr. Marc Donath, has joined the Company’s Clinical Advisory Board (CAB). Dr. Donath, a renowned immuno-endocrinologist, has been recently elected as Medical Director of the Diabetes Centre at the University Hospital Montreal, Canada and is Chief Physician in Endocrinology, Diabetes and Metabolism at the University of Basel, Switzerland...
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​Link to Full Press Release here
Jan

13

As we prepare to launch our pioneering investigator-initiated Phase 2 clinical trial exploring dapansutrile's potential in Parkinson's disease, we are pleased to share a compelling video presented by Cure Parkinson's in collaboration with the University of Cambridge.  Hosted by the prestigious Royal Society of Medicine (RSM), this presentation provides the rationale for targeting the immune system and neuroinflammation in Parkinson’s disease with dapansutrile, a specific NLRP3 inhibitor.

https://lnkd.in/eYSNHVTs

Prior Years News & Events

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Nov

17

Olatec has been invited to present a scientific poster on dapansutrile, one of the most clinically advanced NLRP3 inhibitors, at the American College of Rheumatology 2024 conference, in Washington, DC. This premier event for rheumatology professionals will showcase the latest advancements and research in the field.

Dapansutrile (OLT1177®), a highly specific NLRP3 inhibitor, controls inflammation by selectively targeting the inflammasome without broadly impacting other immune pathways. This specificity reduces off-target effects, potentially offering a safer therapeutic option across multiple diseases. Olatec’s lead clinical trial in acute gout flare, PODAGRA-II (NCT05658575), a Phase 2/3 study, is ongoing. Positive results from this study could transform acute gout flare treatment, offering safer and more effective inflammation management through NLRP3 inhibition.

See abstract (0934) here: https://lnkd.in/ejhQmZjZ
Nov

16

Olatec presented at the American Heart Association Scientific Sessions 2024 in Chicago, sharing a scientific poster on our ongoing Type-2 Diabetes (T2DM) clinical trial, DAPAN-DIA (NCT06047262). This event provides a forum for breakthroughs in cardiometabolic science and medicine, breakthroughs that have the potential to transform therapy practices for cardiometabolic conditions, obesity, and related comorbidities.  Our research focuses on an urgent unmet need for T2DM patients at risk for cardiometabolic and other complications. In our completed study in heart failure, patients showed improvements in heart function (LVEF) and glycemia (fasting glucose) with dapansutrile (OLT1177®) in T2DM.  Olatec’s ongoing clinical trial in T2DM patients will provide critical data on a new, clinically relevant aspect of T2DM care.  We believe that dapansutrile (OLT1177®) has the potential to become a new therapeutic option for T2D patient that addresses both inflammation and cardiometabolic health.
Sep

24-27

Olatec was invited to present a scientific poster on dapansutrile at EMBO Inflammasomes 2024. The EMBO Workshop is bringing researchers together to advance inflammasome biology on September 24-27 in Germany. The poster addresses the need for new assays to be able to reliably assess NLRP 3inhibitors outside of sulfonylureas chemotypes. For example, a new assay called NLRP3 NanoBRET® target engagement assay, does not adequately account for the unique molecular and binding properties of these NLRP3 inhibitors, like hashtag#dapansutrile, a sulfonylnitrile, which has shown a promising safety profile for chronic use.  In their recent Frontiers paper, Tengesdal et al. (2024) highlight the crucial limitations of the NLRP3 NanoBRET® assay in evaluating inhibitors with non-sulfonylurea chemotypes like dapansutrile. Improved methods are essential for accurate screening.
Sep

9-11

Olatec was selected to present BioCentury Inc Grand Rounds event September 9-11 on the clinical status of dapansutrile, our specific NLRP3 inhibitor
Jul

11

First Patient Enrolled in a Phase 2 Study in Patients with Type 2 diabetes with Olatec's NLRP3 Inhibitor, Dapansutrile
  • The first patient with type 2 diabetes mellitus (T2D) and diabetes-related complications has been enrolled in a clinical trial called DAPAN-DIA in Basel, Switzerland, with Olatec's NLRP3 inhibitor, dapansutrile, which is sponsored by Principal Investigator, Marc Donath MD
  • This Phase 2 randomized study is designed to evaluate dapansutrile's efficacy and safety in approximately 300 patients with elevated blood glucose, systemic inflammation and at risk for complications of diabetes, despite use of standard-of-care anti-diabetic therapy
  • DAPAN-DIA represents the first T2D clinical trial of any selective NLRP3 inhibitor in the emerging class that will also assess cardiometabolic and other risk factors beyond anti-hyperglycemic effects including weight lowering efficacy in combination with GLP-1 therapy
  • The trial is being funded by a consortium that includes Olatec, the European Union under the Horizon Europe Programme (GA No 101095433) and the Swiss Government as part of the INTERCEPT-T2D initiative
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​Link to Full Press Release here
NEW YORK, July 11, 2024 /PRNewswire/ -- Olatec Therapeutics, Inc. (Olatec), a leader in the emerging class of specific NLRP3 inhibitors, announced patients with type 2 diabetes mellitus (T2D) and diabetes-related complications (the DAPAN-DIA Study) are being enrolled in a Phase 2 clinical trial in Basel, Switzerland.
June

3-6

Olatec has been selected to present at the BIO 2024 International Convention at the San Diego Convention Center, California on June 4 at 3:45pm in Theater 3.  Please join our CMO, Dr. Mustafa Noor who will discuss the clinical status and data on our NLRP3 inhibitor dapansutrile in gout, cardiometabolic and neuroinflammatory diseases, including data to-date and near-term milestones.
April

18

Dr. Mustafa Noor, Olatec’s CMO, moderates a panel discussion at the annual CMO360 Summit, the largest gathering of biotech Chief Medical Officers.  The panel focused on “Gathering Expertise in New Indications and Modalities”. The CMO Summit 360°® is the largest gathering of biotech Chief Medical Officers across indications and company stages with over 130 biotech companies represented.
Feb

20

Olatec Therapeutics to Conduct a Phase 2 Clinical Trial in Patients with Early Parkinson’s Disease with its NLRP3 Inhibitor, Dapansutrile
  • Cure Parkinson’s has awarded a grant under its International Linked Clinical Trials (iLCT) program to support a clinical study of dapansutrile in patients with early Parkinson’s disease
  • Caroline H. Williams-Gray BMBCh MRCP PhD will serve as Principal Investigator of this Phase 2 trial at the University of Cambridge in the UK, where Dr. Williams-Gray leads the Parkinson’s Disease Research Clinic. The trial will be supported by the Neuroscience Theme of the Cambridge Clinical Trials Unit and the NIHR Cambridge Biomedical Research Centre
  • In this trial, dapansutrile, a specific NLRP3 inhibitor, is intended to target the inflammatory response in Parkinson’s, a novel therapeutic approach that potentially could modify the disease course
  • Patients will be treated for up to 12 months allowing for the potential to measure a disease modifying effect on motor function and non-motor symptoms
  • Movement-associated symptoms associated with Parkinson’s disease arise after significant loss of the dopamine-producing cells of the substantia nigra area of the brain; dapansutrile has previously been found to protect substantia nigra cells in mouse models
  • Parkinson’s disease is considered the fastest growing neurological condition in the world; currently, there are no therapeutics that can alter Parkinson’s disease progression​
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​Link to Full Press Release here
​NEW YORK--(BUSINESS WIRE)--Olatec Therapeutics, Inc. (Olatec), a leader in the developing class of selective NLRP3 inhibitors, today announced that Cure Parkinson’s granted an award to initiate a Phase 2 clinical trial investigating the potential of oral dapansutrile to slow or stop the progression of Parkinson’s disease...
​(click on bold, green text for links)
Dec

10

During a 2023 American Society of Hematology Meeting last week, Dr. Isak Tengesdal presented a poster co-authored with Dr. Charles Dinarello "Metabolic Alterations Associated with Loss of TET2 Potentiates Inflammation in Myeloid Cells Driving Breast Cancer Progression”, demonstrating NLRP3 activation by CHIP alters the tumor microenvironment in breast cancer progression, and inhibiting NLRP3 with dapansutrile slows tumor growth.
Nov

1

Congratulations to our science team on their state of the science review of NLRP3 activation in cancer that describes the multiple roles of NLRP3 in several solid tumors.  Dapansutrile and other specific NLRP3 inhibitors are referenced in the publication as potential therapeutic candidates for continued investigation. (see publication here).  
Oct

3

​Olatec Therapeutics Announces Publication of Preclinical Research on Oral NLRP3-Specific Inhibitor Dapansutrile in Pancreatic Ductal Adenocarcinoma
  • Olatec’s dapansutrile, an NLRP3 inhibitor, was studied in a preclinical model of pancreatic ductal adenocarcinoma (PDAC)
  • This study furthers our understanding of the role of NLRP3 in PDAC by showing how PDAC cells are able to induce NLRP3 activation and consequently promote tumor progression and immunosuppression
  • Inhibition of NLRP3 with dapansutrile was shown to reduce tumor progression in mice by restoring an effective anti-tumor immunity
  • Dapansutrile increased survival in mice in these PDAC studies
  • Dapansutrile was also shown to increase the efficacy of standard chemotherapy in PDAC supporting its potential as therapeutic target
  • The findings from Olatec’s PDAC research expands its preclinical data platform, generated previously in melanoma and breast cancer, showing tumor reduction by treating NLRP3 driven inflammation with dapansutrile
  • Dapansutrile is being investigated at the Duke Cancer Institute in an ongoing clinical trial as a combination therapy with pembrolizumab (Keytruda®) in treating patients with PD-1 refractory advanced melanoma
NEW YORK--(BUSINESS WIRE)---Olatec Therapeutics LLC (Olatec), a leader in the developing class of oral selective NLRP3 inhibitors, today announced a publication in Cancer Research Communications showing a reduction in tumor progression with dapansutrile as a monotherapy, resulting from inhibition of NLRP3/IL-1β pathway in mouse models of pancreatic ductal adenocarcinoma (PDAC). Additionally, the data show that dapansutrile, when administered in combination therapy with gemcitabine significantly increased efficacy of this chemotherapy.
​Link to Full Press Release here
June

22

Olatec’s publication in Journal of Neuroinflammation demonstrates that targeting the NLRP3 inflammasome by dapansutrile (OLT1177®), which crosses the blood brain barrier, reduces levels of α‑synuclein, protects dopaminergic neurons, improves locomotor function and could have the potential to become a safe and novel therapeutic approach that could arrest neuroinflammation and protect against neurological deficits of Parkinson’s disease in humans (see publication here).   Additional studies supported by the Michael J. Fox Foundation are ongoing (see here)
May

16

Olatec Therapeutics Announces the Completion of First Dose Cohort in an Innovative Trial Investigating Olatec’s NLRP3 Inhibitor Dapansutrile and Merck’s Keytruda® in Patients with Advanced Refractory Melanoma at Duke Cancer Institute
  • Olatec’s dapansutrile - considered to be the first oral NLRP3 inhibitor tested in patients with advanced refractory melanoma - is addressing the inflammatory driven resistance to anti-PD-1 therapies, a large and growing unmet medical need
  • NLRP3 inhibition with dapansutrile reduces the pro-tumor inflammatory cytokine, IL‑1β, in human melanoma cells, and restores immune surveillance function leading to reduced tumor progression in mouse models
  • The DREAM (DapansutRile Plus PEmbrolizumab in Patients with PD-1 Refractory Advanced Melanoma) Trial is assessing dapansutrile in combination with pembrolizumab (Keytruda®), under Principal Investigator April Salama MD, Head of Duke Cancer Institute’s Melanoma Program
  • The first cohort of the DREAM Trial completed enrollment, showing no dose limiting toxicity allowing escalation to the second and highest dose cohort of the study
NEW YORK--(BUSINESS WIRE)---Olatec Therapeutics LLC (Olatec), a leader in the developing class of selective NLRP3 inhibitors, today announced it has completed the lower dose cohort and entered the second, and highest, dose cohort of the DREAM Trial, a Phase 1/2 Investigator-initiated clinical study (NCT04971499). This trial is evaluating the combination treatment of Olatec’s dapansutrile, an NLRP3 inhibitor, and pembrolizumab (Keytruda®) in patients with PD-1 refractory advanced melanoma. The study is being led by Principal Investigator (PI), April Salama MD, Head of the Melanoma Program at The Duke Cancer Research Institute and supported by Olatec and Merck & Co., Inc. (Merck). The aim of the DREAM Trial is to address the unmet need in patients with PD-1 refractory advanced melanoma.
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​Link to Full Press Release here
Mar

10

Olatec Therapeutics Awarded a Grant from The Michael J. Fox Foundation in Collaboration With Medical University of Innsbruck to Evaluate Dapansutrile in Animal Models of Parkinson’s Disease Progression
The Michael J. Fox Foundation for Parkinson’s Research (MJFF) has awarded a grant from their Therapeutics Pipeline Program to support preclinical research evaluating Olatec Therapeutics’ lead compound, dapansutrile, in Parkinson’s disease (PD)
  • Under this grant Olatec, in collaboration with Dr. Nadia Stefanova (Medical University of Innsbruck), will be studying dapansutrile in both wildtype and transgenic mice with α-synuclein inclusion pathology to assess dapansutrile’s effect on motor symptoms and lowering neuroinflammation and plaque formation
  • PD motor clinical symptoms are thought to arise after substantial loss of the dopamine-producing cells of the substantia nigra; currently, there are no therapeutics that can alter PD progression
  • Dapansutrile has previously been found to protect substantia nigra cells in another PD mouse model
NEW YORK--(BUSINESS WIRE)--Olatec Therapeutics LLC (Olatec), a leader in the developing class of selective NLRP3 inhibitors, today announced that The Michael J. Fox Foundation for Parkinson’s Research (MJFF) awarded a research grant to evaluate Olatec’s lead molecule, dapansutrile, in preclinical Parkinson’s disease (PD) progression models. These studies are being initiated in collaboration with researchers at the Medical University of Innsbruck in Austria. The studies will assess dapansutrile’s potential effect as an anti-neuroinflammatory agent, and its pharmacokinetics to confirm validated target engagement in certain transgenic and propagation mouse models. The aim of this collaboration is to accelerate the development of a potential therapeutic intervention that may prevent or mitigate the development of PD’s motor and non-motor symptoms.​
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​Link to Full Press Release here
Feb

23

Olatec Therapeutics Announces the Final Closing, Led by Sanders Morris Harris, on Its $40 Million Series A Financing Round​
NEW YORK--(BUSINESS WIRE)--Olatec Therapeutics LLC (“Olatec” or the “Company”), a leader in developing NLRP3 inhibitors, announced the completion of the Company’s $40 million Series A round financing, the final closing of which was led by Sanders Morris Harris (“SMH”). Participation in the round came from both existing investors as well as new investors identified by each of Sanders Morris Harris, Advection Growth Capital and the Company. Proceeds will be principally used to advance Olatec’s lead compound, dapansutrile, into later stage clinical development.
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​Link to Full Press Release here
​(click on bold, green text for links)
Nov

16

Olatec CSO, Charles Dinarello to speak at UVA on the Past, Present and Future of IL-1 
Olatec's CSO Charles Dinarello to speak at UVA tomorrow (11/17) at the RMB CVRC Seminar, hosted by SAB Member, Antonio Abbate: Past, Present and Future of Interleukin-1 in Human Disease.
Nov

14

Olatec Data Presented at 2022 American College of Rheumatology Convergence 
During a Scientific Session at the 2022 American College of Rheumatology Conference, entitled "Gout Is an Autoinflammatory Metabolic Disease", Michael Pillinger, Charles Dinarello and Naomi Schlesinger discuss the autoinflammatory nature of gout, demonstrating it as one of the truly IL-1 β -mediated diseases.   They discuss research conducted in understanding the role NLRP3 inflammasome in gouty inflammation and review treatments of acute gout flares, including dapansutrile's clinical data.
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Nov

7

Jesús Amo Aparicio presents poster, "Pharmacologic inhibition of NLRP3 reduces the levels of α-synuclein and protects dopaminergic neuronsin a model of Parkinson’s disease” at 2022 Neuroscience Meeting
Aug

16

Craig T. Basson, MD, PhD Joins Olatec Therapeutics’ Board of Directors
NEW YORK--(BUSINESS WIRE)--Olatec Therapeutics LLC, a leader in the developing class of selective NLRP3 inhibitors, today announced that Craig T. Basson, MD, PhD has been elected to their Board of Directors.

​Excited to join Olatec’s Board of Directors, Dr. Basson explained: “I am thrilled to contribute to Olatec’s development of lead compound, dapansutrile – starting in gouty arthritis and to realize [dapansutrile’s] potential to translate the science of the NLRP3 inflammasome in multiple disease areas. I am confident in Olatec’s ultimate ability to deliver this important medicine globally to the many patients suffering from inflammatory diseases.”...
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​Link to Full Press Release here
May

7

Lars Lunding presents poster, "The NLRP3 Inflammasome Inhibitor OLT1177® Ameliorates Experimental Allergic Asthma in Mice” at 2022 Immunology Meeting
Apr

19

Olatec's Donation to the Ukranian People Received
We are pleased to report that the Ukrainian people in need of aid and medical supplies received our donation of certain OTC pain medication. We thank ABF Pharmaceutical Services GmbHfor their teamwork in this effort
Mar

15

Mustafa Noor, MD, FACP, Joins Olatec as Chief Medical Officer​
NEW YORK--(BUSINESS WIRE)--Olatec Therapeutics LLC, a leader in the developing class of selective NLRP3 inhibitors, today announced that Mustafa Noor, MD, FACP, joins the Company as Chief Medical Officer (CMO), following the decision of current CMO, Dr. Curt Scribner, to retire from the position.

​Dr. Noor remarked: “I believe this is a great time to be joining the Olatec team. I see Olatec at a major value inflection point and am excited to not only build on the world class translational science that has been elucidated, but help this exceptional team take dapansutrile through late-stage development and prospectively its approval in the lead indications.” Dr. Noor continued, “Olatec is at the forefront of a compelling new inflammation target across multiple disease areas, which creates many opportunities for dapansutrile and the OLT Analogue compounds.”...
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​Link to Full Press Release here
Feb

15

Olatec Announces High-Impact Coverage of Dapansutrile in Leading Journal on Cardiovascular Disease as well as Another Publication from New Preclinical Data in a Heart Failure Model
  • Cardiovascular disease (CVD), a leading cause of death and disability worldwide, involves structural and functional changes in the heart
  • Local sterile inflammation by the innate immune system results in a signaling cascade, particularly activation of NLRP3
  • NLRP3 activation, along with processing and release of downstream associated pro-inflammatory cytokines, IL-1β and IL-18, are now established as significant drivers in the development of heart failure
  • The Journal of the American College of Cardiology (JACC): Basic to Translational Science, a leading CVD publication, recently published a review on the NLRP3 inflammasome as significant CVD target
  • This seminal review publication cited the results of Olatec’s dapansutrile study in patients with stable heart failure (HF) with reduced ejection fraction (HFrEF) calling dapansutrile “the most interesting and promising study for patients with HF”
  • The JACC review described dapansutrile’s results including its ability to improve heart health markers after a 2-week treatment
  • New data from Olatec’s preclinical program in CVD published in Molecules, continue to support that dapansutrile, a selective NLRP3 inhibitor, targets the sterile inflammation pathway resulting in improved cardiac outcomes in a model of heart failure
Link to JACC Review here and Molecules Publication here
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​Link to Full Press Release here
Oct

4-6

Olatec data from our preclinical studies using an Alzheimer’s disease model presented at Düsseldorf-Jülich Symposium on Neurodegenerative Diseases: Aggregates, Autophagy, Prions and Biomarkers on October 4-6, with Martin Korte PhD from TU Braunschweig, Germany presenting
Oct

4-5

Olatec data from our preclinical studies using an Alzheimer’s disease model presented at International Conference on Alzheimer’s Drug Discovery on October 4-5, with Niklas Lonnemann PhD candidate from TU Braunschweig, Germany presenting 
Oct

1

Olatec data from our clinical Heart Failure trial and preclinical AMI studies, respectively, presented at Inflammasomes Symposium on October 1, hosted by Virginia Commonwealth University Center for Clinical and Translational Research with with Antonio Abbate MD (moderator), and Ben van Tassel MD and Stefano Toldo PhD from VCU presenting
Aug

24

Andrea Leonard-Segal, MD, FACR Joins Olatec’s Scientific Advisory Board and Becomes Medical Monitor in the Upcoming Gout Trial
NEW YORK--(BUSINESS WIRE)--Olatec Therapeutics LLC, a leader in the developing class of selective NLRP3 inhibitors, today announced that Andrea Leonard-Segal, MD, FACR joins the Company’s Scientific Advisory Board (SAB), and in tandem, assumes the role of Medical Monitor in the upcoming Phase 2b trial in the lead indication, acute gout flares... Continue Reading
Jul

21

Gregory K. Palm Joins Olatec Therapeutics’ Board of Directors
NEW YORK--(BUSINESS WIRE)--Olatec Therapeutics LLC, a leader in the developing class of selective NLRP3 inhibitors, today announced that Gregory K. Palm, currently a senior advisor to The Goldman Sachs Group, has been elected to Olatec’s Board of Directors in connection with his making a substantial equity investment in the Company... Continue Reading
Jul

8

Alberto Mantovani, MD Joins Olatec Therapeutics’ Scientific Advisory Board
NEW YORK--(BUSINESS WIRE)--Olatec Therapeutics LLC is very pleased to welcome Alberto Mantovani MD to its Scientific Advisory Board.  Dr. Mantovani is world renown for his seminal work on the link between inflammation and cancer, demonstrating how a chronic inflammatory response promotes the development and metastasis of cancer. Dr. Mantovani's studies paved the way to change the view of the nature of cancer, from a tumor cell-centric focus, to one that includes the systemic role of immune cells as an essential component of neoplasia, i.e., abnormal growth of tumor cells. Dr. Mantovani's paradigm shift is now reflected in the development of immunotherapy for cancer, as currently approved... Continue Reading
Apr

28

Olatec Therapeutics Announces Results Showing Dapansutrile Reduces Tumor Growth in a Mouse Model of Melanoma 
NEW YORK-- (BUSINESS WIRE) -- Olatec Therapeutics LLC (Olatec) today announced the first publication from its preclinical studies with dapansutrile in selected cancer models. The data in this paper, entitled “Targeting tumor-derived NLRP3 reduces melanoma progression by limiting MDSCs expansion”, is published in the Proceedings of the National Academy of Sciences (PNAS). Under leading investigators including, Charles Dinarello MD, Olatec’s CSO, and Mayumi Fujita MD PhD, the data show that blocking NLRP3 with oral dapansutrile resulted in a significant reduction in tumor growth and progression when compared to untreated mice with induced melanoma...Continue Reading
Apr

14

Denver Business Journal’s, Jensen Werley, reports on Olatec’s currently enrolling Phase 2 clinical trials in COVID-19 and its local partnership with leading respiratory center National Jewish Health.   As reported, Olatec is enrolling patients in a Phase 2 clinical trial in the USA and Europe which is aimed at treating patients with its oral NLRP3 inhibitor, dapansutrile, early in the course of the disease to prevent progression into severe disease stages of inflammation requiring hospitalization.  As added by Principal Investigator and pulmonologist at National Jewish Health, Dr. Michael Wechsler, in the Denver Business Journal, ‘it’s still important to have therapies available for those patients that do get sick with Covid-19’.

Click here to read article, Biotech company partners with National Jewish Health to test potential Covid-19 therapy for more.
Apr

6

Olatec’s lead compound, dapansutrile, featured in  "A Drug That Can Stop Tumors From Growing” published by Greg Glasgow at University of Colorado Anschutz Medical Campus.  The article focuses on the positive results from our melanoma studies showing a reduction of tumor growth and progression.  We congratulate Drs. Charles Dinarello, Mayumi Fujita, Carlo Marchetti, Isak Tengesdal, James DeGregori, Angelo D'Alessandro, Morkos Henen, Beat Vögeli, Eric Pietras.
Apr

1

Olatec referenced in "Pharma Looks to Inflammasome Inhibitors as All-Around Therapies”, an article published in The Scientist®.
February

26

Following the Marchetti et al study posted in bioRxiv, News Medical published, “NLRP3 inflammasome inhibitors may help treat early COVID-19, says study” which cites oral dapansutrile, specific NLRP3 inhibitor.  This commentary makes the case for early NLRP3 inhibition which "might prevent the need for hospitalization and ease the enormous burden currently being placed on healthcare services"
February

24

Charles Dinarello MD, Carlo Marchetti PhD, Isak Tengesdal, William Janssen, Kara Mould posted a paper entitled “Targeting of the NLRP3 Inflammasome for early COVID-19” in bioRxiv .  
In human plasma samples of patients newly infected with SARS-CoV-2, the data from the manuscript show NLRP3 activation leading to the production of the primary cytokine,
 IL-1β, early in the disease cycle.  This paper further reinforces Olatec’s clinical trial (NCT04540120) with selective NLRP3 inhibitor, dapansutrile, in non-hospitalized patients with COVID-19  
February

11

Olatec Therapeutics LLC Announces a Scientific Publication on the Positive Results in the First Known Clinical Trial with a Selective Oral NLRP3 Inhibitor, Dapansutrile, in Patients with Heart Failure
NEW YORK--(BUSINESS WIRE) -- Olatec Therapeutics LLC (Olatec) today announced the publication of the clinical data on its Phase 1b clinical study of patients with heart failure with reduced ejection fraction (HFrEF). Published in the Journal of Cardiovascular Pharmacology, the study met its primary objectives showing dapansutrile is safe and well tolerated in patients in all dose groups…Continue Reading
December

29

Olatec Therapeutics’ Lead Compound, Dapansutrile, a Selective NLRP3 Inhibitor, Prevents the Inflammatory Response and Restores Cognitive and Behavioral Deficits in a Mouse Model of Alzheimer’s Disease 
NEW YORK--(BUSINESS WIRE) -- Olatec Therapeutics LLC (“Olatec”) today announced the publication of data demonstrating the benefits of its selective NLRP3 inhibitor, dapansutrile, in a mouse model of Alzheimer’s Disease (AD). The data are published in the journal Proceedings of the National Academy of Sciences of the United States of America (PNAS). The study shows oral dosing with dapansutrile inhibits pathophysiological inflammatory processes, recovers significant cognitive losses and prevents neuroinflammation in the brains of transgenic mice induced with Alzheimer’s Disease (AD)…Continue Reading
December

22

In the Journal of Medicinal Chemistry, Olatec is cited to have “presented phase II data for its compound dapansutrile in acute gout. This is, at the moment, the most clinically advanced NLRP3 inhibitor”, as stated in Strategies for Targeting the NLRP3 Inflammasome in the Clinical and Preclinical Space
October

27

Olatec Enrolls its First Patients in a Phase 2 Placebo-Controlled Clinical Trial in COVID-19 with its Selective NLRP3 Inhibitor, Oral Dapansutrile
(New York, NY — October 27, 2020) Olatec Therapeutics LLC announced today that it is currently enrolling non-hospitalized COVID-19 patients with the aim to treat and prevent damaging effects of IL-1-induced inflammation that can lead to a fulminant Cytokine Storm. The trial is described as: “A Phase 2 Randomized, Double-Blind, Placebo-Controlled Trial of the Safety and Efficacy of Orally Administered Dapansutrile Capsules for the Treatment of Moderate COVID-19 Symptoms and Evidence of Early Cytokine Release Syndrome.” … Continue Reading
June

29

One of the world’s premier societies of cardiology, the European Society of Cardiology (ESC), accepted the abstract, “Safety of a novel oral NLRP3 inflammasome inhibitor, dapansutrile (OLT1177), in patients with stable heart failure with reduced ejection fraction” as a virtual poster at ESC’s 2020 Congress. 

Olatec's poster presents the positive results of our Phase 1b Heart Failure Study, in which Dr. Antonio Abbate, leading cardiologist at Virginia Commonwealth University, was the Principal Investigator on the study. In his assessment of the study outcome, Dr. Abbate states, “We are all enthusiastic about the continued development of dapansutrile in cardiovascular disease and its clean safety profile. Dapansutrile's findings provide preliminary safety evidence and data for NLRP3 inhibition in patients who are expected to poorly tolerate side effects of NSAIDs or glucocorticoids."

 About ESC: ESC represents more than 95,000 professionals in the field of cardiology, focused on understanding the impact of cardiovascular disease and how we can better reduce its burden.

June

23

A Frontiers in Immunology publication, entitled "Targeting the NLRP3 Inflammasome in Severe COVID-19”, underscores the validation of the NLRP3 target in treating cytokine release syndrome in COVID-19.  Table 1 of the publication cites Olatec’s lead compound, dapansutrile, as the most advanced selective NLRP3 inhibitor in Phase 2 clinical trials in a broad spectrum of diseases.
June

19

Olatec’s CSO & SAB chair, Charles Dinarello MD announced as a joint winner of the 2020 Tang Prize in Biopharmaceutical Science for his groundbreaking achievements establishing IL-1β as a potent mediator of fever and inflammatory diseases.  

“[Dinarello laid the groundwork for] the development of biopharmaceuticals that have benefited millions of people suffering from autoimmune and inflammatory diseases”, said the Tang Prize Foundation said today.  The Tang Prize Foundation, established in 2012, awards its biannual prize across four categories, including scientists that aim to find a 21st century path to the sustainable development of the world.


Link to article's  here and here, and watch a video of Dr. Dinarello’s acceptance of the 2020 Tang Prize, where Charles documents his monumental discovery of IL-1β, a potent mediator of fever and inflammatory diseases.
May

11

Reuters Health published, in Medscape, “Dapansutrile Appears Safe, Effective in Gout Patients”.  The article quotes Dr. Michael H. Pillinger of NYU School of Medicine/NYU Langone Medical Center, “Now, thanks to a decade of advances in inflammation science, we understand the central role of the NLRP3 inflammasome, and of IL-1β in particular, in the pathogenesis of gout…This understanding has allowed the development of dapansutrile, which is likely destined to become the first agent designed specifically to treat gouty inflammation...” 
Apr

23

Olatec’s NLRP3 inhibitor, dapansutrile, is cited in "Interleukin-1 and the Inflammasome as Therapeutic Targets in Cardiovascular Disease” in the Circulation Research, in which the publication stated, “There is overwhelming evidence linking the NLRP3 inflammasome and the IL-1 cytokines with the pathogenesis of CVDs." 
Apr

8

Olatec’s CSO, Charles Dinarello MD, discusses dapansutrile, an oral NLRP3 inhibitor, as an optimal target to prevent and treated the inflammatory cytokine storm in COVID-19 patients, during a grand rounds featured presentation for Colorado University’s Department of Medicine.
See also CU News Release.
Apr

7

We are pleased to report that The Lancet Rheumatology published our paper, "Dapansutrile, an oral selective NLRP3 inflammasome inhibitor, for treatment of gout flares: an open-label, dose-adaptive, proof-of-concept, phase 2a trial" along with a third-party commentary entitled, "Dapansutrile: a new hope?". Olatec's publication presents the successful results of our clinical proof of concept trial for dapansutrile in acute gout. Acute gout was strategically selected as it is a prototypical NLRP3 mediated disease, validating the potential for our NLRP3 inhibitor in a broad spectrum of inflammatory diseases.  
Feb

17

Olatec cited in the C&EN cover story entitled “Could an NLRP3 inhibitor be the one drug to conquer common diseases?”
Nov

11-12

At the world’s leading organization for rheumatology health professionals - Olatec presented its datasets demonstrating significant clinical antiinflammatory effect and clean safety profile with oral dapansutrile in the treatment of acute gout attacks in oral and poster presentations.  The acceptance of these two abstracts by American College of Rheumatology (ACR) and Association of Rheumatology Professionals (ARP) for presentations at their 2019 Annual Meeting in Atlanta, Georgia provides further validation of the positive results in our first human Phase 2 trial of an oral NLRP3 inflammasome inhibitor.  About ACR/ARP: since its beginnings over 80 years ago, today, ACR draws more than 16,000 attendees from more than 100 countries to its Annual Meeting each year.   (In compliance with ACR’s disclaimer requirements, this news release is being made solely by Olatec).
Nov

1

Olatec’s fourth peer-reviewed publication and first publication on the benefits of dapansutrile in preclinical models of neurodegenerative disease, specifically in multiple sclerosis (MS), published in Frontiers Immunology. In this publication, “OLT1177 (dapansutrile), a selective NLRP3 inhibitor, ameliorates experimental autoimmune encephalomyelitis pathogenesis,” we show that oral treatment of dapansutrile – an NLRP3 inhibitor – delays and reduces disease progression in a mouse model of MS. These data provide justification of the potential clinical benefit of dapansutrile in MS patients. Frontiers Immunology ranks as the 5th most-cited publisher among the 20 largest publishers in 2019.
Link to publication, here.   
Oct

14

Charles Dinarello MD, co-CSO and Chairman of Olatec’s Scientific Advisory Board, presents “Treating Inflammation with IL-1 Blockade from Gout to Cancer”, in which he presents data on dapansutrile, at ITMAT’s 14th Annual International Symposium – Translational Targets and Precision Medicine: Taming Inflammation and Improving Resilience as We Age in Philadelphia, PA.
Oct

1

Carlo Marchetti, PhD, Director for Olatec’s Innovative Science Program in Dr. Charles Dinarello’s Laboratory​, publishes a review entitled “The NLRP3 inflammasome as pharmacological target”, in the Journal of Cardiovascular Pharmacology, in which Olatec’s lead compound, dapansutrile, is referenced
Read More
Oct

1

A review of Olatec’s lead compound, dapansutrile (lab code: OLT1177®), appears in the Journal of Cardiovascular Pharmacology publication entitled “Inhibiting NLRP3 Inflammasome Activity in Acute Myocardial Infarction: A Review of Pharmacologic Agents and Clinical Outcomes”co-authored by Leo F. Buckley, PharmD and Olatec Scientific Advisory Board Member, Peter Libby, MD.
Read More
Sep

12

Olatec’s lead compound (OLT1177® dapansutrile) referenced in Nature Reviews Rheumatology publication by Charles Dinarello MD, CSO and Chairman of Olatec’s Scientific Advisory Board entitled, "The IL-1 family of cytokines and receptors in rheumatic diseases". The publication represents a further validation for dapansutrile in its acute gout flares and osteoarthritis clinical indications.
Read More
Sep

9

The Company established Olatec Therapeutics BV, a wholly-owned subsidiary in the Netherlands (“Olatec BV”). 
Sep

1

Olatec’s lead compound, dapansutrile, referenced in Journal of Cardiovascular Pharmacology publication entitled, "Drugs to Inhibit the NLRP3 Inflammasome: Not Always On Target"
Read More
Sep

1

Olatec’s lead compound, dapansutrile, referenced in Journal of Cardiovascular Pharmacology publication entitled, "Cardiovascular Pharmacology of the NLRP3 Inflammasome"
Read More
Sep

1

Olatec’s lead compound, dapansutrile, referenced in Journal of Cardiovascular Pharmacology publication entitled, "NLRP3 Inflammasome in Acute Myocardial Infarction"
Read More
Aug

28

Olatec Therapeutics announces that dapansutrile met its primary and secondary endpoints in a Phase 2a trial (Study OLT1177-05) of patients with acute gout flares.  This trial represents the first known selective NLRP3 inhibitor to demonstrate clinical benefit, safety and a reduction in systemic inflammation.  Datasets on the clinical, inflammatory biomarker and safety outcomes will be presented this November at a prestigious conference.
Jun

13

Olatec’s lead compound, dapansutrile, referenced in Gout 1st Edition book entitled, "Gout: Chapter 17 Drugs in the Pipeline”, authored by Naomi Schlesinger, MD
Read More
Jun

10

Olatec’s lead compound, dapansutrile, referenced in the Journal of Allergy and Clinical Immunology publication entitled, "A novel knock-in mouse model of cryopyrin-associated periodic syndromes with development of amyloidosis: Therapeutic efficacy of proton pump inhibitors”
Read More
Apr

29

Olatec’s lead compound, dapansutrile, referenced in Nature Reviews Immunology publication entitled, ”The NLRP3 inflammasome: molecular activation and regulation to therapeutics"
Read More
Apr

23

Olatec’s lead compound, dapansutrile, referenced in EMBO Molecular Medicine publication entitled, ”Inflammasomes in neuroinflammatory and neurodegenerative diseases"
Read More
Mar

31

Charles Dinarello MD, CSO and Chairman of Olatec’s Scientific Advisory Board presents select data on dapansutrile at the 10th Biannual Meeting of the International Society of Systemic Auto-Inflammatory Diseases (ISSAID) in Genoa, Italy.
Feb

12

Olatec’s lead compound, dapansutrile, referenced in Nature Cell Death & Disease publication entitled, “Recent advances in the mechanisms of NLRP3 inflammasome activation and its inhibitors”
Read More
Feb

10

Timotheus L.Th.A. Jansen, MD PhD joins and becomes Chairman of the Olatec Clinical Advisory Board.  Mr. Jansen has been contributing leading expertise in the design and conduct of Olatec’s human clinical trials in gout including serving as the principal investigator of the first clinical trial with dapansutrile for acute gout flares.
See Bio
Feb

8

Olatec manuscript published in Journal of Cardiovascular Pharmacology entitled, "The NLRP3 Inflammasome Inhibitor, ​OLT1177 (Dapansutrile), Reduces Infarct Size and Preserves Contractile Function After Ischemia Reperfusion Injury in the Mouse”
Read More
December

21

Olatec’s lead compound, dapansutrile, referenced in Cardiovascular Research publication entitled, “Innate immunity as a target for acute cardioprotection”
Read More
November

21

Bob Fielding joins the Olatec Scientific Advisory Board.  Mr. Fielding is contributing leading expertise in the design and conduct of Olatec’s pharmacology programs.  Mr. Fielding has over 30 years experience in the pharmaceutical and biotech industries, including with formulation evaluation, preclinical pharmacokinetics/toxicokinetics, pharmacology and clinical pharmacokinetic studies for more than 30 products now approved or in clinical trials. 
See Bio
November

21

Steve Newhard joins the Olatec Scientific Advisory Board. Mr. Newhard has over 40 years of experience in the pharmaceutical and regulatory industry and is responsible for manufacturing of Olatec's Lead Compound at CMOs producing the active drug substance and drug product.
See Bio
September

5-7

Charles Dinarello MD, CSO and Chairman of Olatec’s Scientific Advisory Board, and Leo Joosten PhD, Olatec SAB Member, presents select data on dapansutrile at the New Frontiers in Innate Immunity & Inflammation in Cluj Napoca, Romania.
August

31

Olatec referenced in American Journal of Physiology-Heart and Circulatory Physiology publication entitled, “Inflammasome, Pyroptosis, and Cytokines in Myocardial Ischemia-Reperfusion Injury”
Read More
August

3

Olatec manuscript published in Arthritis Research & Therapy entitled, "NLRP3 inflammasome inhibitor OLT1177 suppresses joint inflammation in murine models of acute arthritis”
Read More
July

20

Olatec’s lead compound, dapansutrile, referenced in Nature Reviews Drug Discovery publication entitled, "Targeting the NLRP3 inflammasome in inflammatory diseases”
Read More
April

4

Olatec referenced in Nature Scientific Reports publication entitled,"Development of a characterised tool kit for the interrogation of NLRP3 inflammasome-dependent responses”
Read More
March

1

Charles Dinarello MD, CSO and Chairman of Olatec’s Scientific Advisory Board, presents select data on dapansutrile at the European Crystal Network Workshop in Paris, France.
February

23

Olatec referenced in European Heart Journal, published on behalf of European Society of Cardiology, entitled, "Interleukin-1 blockade in cardiovascular diseases: a clinical update”
Read More
January

29

Olatec’s research manuscript published in Proceedings of the National Academy of Sciences, entitled "OLT1177, a β‑sulfonyl nitrile compound, safe in humans, inhibits the NLRP3 inflammasome and reverses the metabolic cost of inflammation”.
Read More
November

12

Stefano Toldo, PhD, Virginia Commonwealth University Assistant Professor, Department of Internal Medicine Division of Cardiology, presents poster, “Novel NLRP3 Inflammasome Inhibitor OLT1177 Reduces Infarct Size in a Mouse Model of Myocardial Ischemia Reperfusion Injury” at the AHA conference in Anaheim, CA
Read More
November

16

Olatec referenced in Nature Reviews Cardiology entitled, "The NLRP3 inflammasome in acute myocardial infarction”
Read More
October

11

Olatec referenced in Nature Biotechnology entitled, “Novartis trial validates inflammasome as chronic disease driver” 
Read More
June

14

Carlo Marchetti, PhD, Director for Olatec’s Innovative Science Program in Dr. Charles Dinarello’s Laboratory​, presents, “The Human Safe NLRP3 Inflammasome Inhibitor OLT1177 Suppresses Joint Inflammation in Murine Models of Experimental Arthritis” at EULAR conference in Madrid, Spain
See Bio, Read More
April

21

Carlo Marchetti, PhD, Director for Olatec’s Innovative Science Program in Dr. Charles Dinarello’s Laboratory​, presents poster, “The Novel and Safe Pharmaceutical Compound OLT1177 Reduces Inflammation by Preventing Activation of the NLRP3 inflammasome” at AAP/ASCI/APSA Meeting in Chicago, IL
See Bio, Read More
March

19

Antonio Abbate, MD, PhD joins the Olatec Scientific Advisory Board. Dr. Abbate is a prominent leader in the field of cardiovascular disease​
See Bio
November

27

Franz Hefti, PhD joins the Olatec Scientific Advisory Board.  Dr. Hefti is a prominent leader in the development of neurodegenerative therapeutics and an experienced biotech CEO
See Bio

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