Olatec
Leading the Development of Specific NLRP3 Antagonists,
​ Mediator of Innate Inflammatory Response     
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Recent News & Events

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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
February

5

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 the article, Strategies for Targeting the NLRP3 Inflammasome in the Clinical and Preclinical Space
December

29

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
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
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

28

Olatec’s lead compound, dapansutrile, referenced in Arthritis & Research publication entitled, "The Clinicopathologic Significance of Inflammasome Activation in Autoimmune Diseases"
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
Jun

4

Olatec’s lead compound, dapansutrile, referenced in Nature Reviews Nephrophology publication entitled, " The role of inflammasomes in kidney disease”
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.
Mar

21

Olatec’s lead compound, dapansutrile, referenced in The Journal of Organic Chemistry publication entitled, "Discovery of Quinazolin-4(3H)-ones as NLRP3 Inflammasome Inhibitors: Computational Design, Metal-free Synthesis and In-vitro Biological Evaluation”
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Mar

4

Olatec’s lead compound, dapansutrile, referenced in Kidney International publication entitled, “Multifactorial functions of the inflammasome component NLRP3 in pathogenesis of chronic kidney diseases”
Read More
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
December

4

Olatec’s lead compound, dapansutrile, referenced in Frontiers in Neurology publication entitled, “Rusty Microglia: Trainers of Innate Immunity in Alzheimer's Disease”
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

14

Olatec’s lead compound, dapansutrile, referenced in Psychoneuroendocrinology publication entitled, “Emerging role of the P2X7-NLRP3-IL1β pathway in mood disorders”
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
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

16

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

11

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