OLT1177™ dapansutrile exhibits exceptional attributes as a pharmaceutical product, most notably: compelling nonclinical efficacy and early clinical benefit, no observed human toxicity, an attractive pharmacokinetic profile and low cost of goods. Dapansutrile has a unique pharmacological profile, inhibiting inducible interleukin (IL)-1β and IL-18 production.
Dapansutrile's Clean Safety Profile
Olatec has completed four clinical trials with dapansutrile to date: one Phase 1 study in the oral dosage form as well as one Phase 1 and two Phase 2 studies in the topical dosage form. Across all four of these placebo-controlled clinical studies, dapansutrile has been found to be safe and well tolerated. No treatment-emergent serious adverse events have occurred. 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 study with the oral formulation of dapansutrile. In that study, as in all of its other studies to date, dapansutrile exhibited a remarkably clean safety profile. Olatec has three active ‘proof of concept’ Phase 2 human clinical trials for the first indications being targeted in: acute gout flares, Cardiovascular disease and a rare disease.
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.