OLT1177® dapansutrile exhibits exceptional attributes as a pharmaceutical product, most notably: compelling nonclinical efficacy and clinical benefit, no observed human toxicity, an attractive pharmacokinetic profile and low cost of goods.
Dapansutrile's Clean Safety Profile
In all seven clinical trials to date, Olatec has demonstrated a clean safety profile, with no treatment-emergent serious adverse events occurring. Additionally, none of the measured laboratory parameters, or cardiac or respiratory measures have indicated any safety issue with dapansutrile.
Dapansutrile's Clinical Experience to date
Olatec has completed a Phase 1 safety study in healthy volunteers and a Phase 2 ‘proof of concept’ study in acute gout flares, in which oral dapansutrile met its primary and secondary endpoints. Based on the positive results from this study, the Company is preparing to launch its next Phase 2 trial in 2020. In addition to the gout program, Olatec is currently conducting a Phase 2 ‘proof of concept’ study in rare disease and a Phase 1b study in cardiovascular disease. In these and all its other studies to date, oral dapansutrile has exhibited a remarkably clean safety profile.
Olatec has completed two placebo-controlled Phase 2 studies with the topical formulation of dapansutrile in patients with osteoarthritis (OA). In both the 2-week Phase 2 study as well as the 6-week Phase 2 study, topically applied dapansutrile demonstrated a reduction of pain that significantly exceeded the Minimal Clinically Important Improvement (MCII) as established in the literature . In both studies, the reduction of pain was most pronounced in the subset of subjects with more severe and advanced OA. In all three studies, dapansutrile exhibited a remarkably clean safety profile. Following approval in the OA indication, the Company plans to expand the label for the topical treatment of chronic musculoskeletal pain.
Other Disease Indications Currently in Preclinical Development for Dapansutrile
Several preclinical studies are ongoing in translational animal models to establish the disease-modifying activity of dapansutrile in a number of other conditions that have been established as IL-1β mediated diseases.