Vitae Pharmaceuticals Inc (NASDAQ:VTAE), a clinical-stage biotech entity, reported encouraging top-line results from its Phase IIa proof-of-concept clinical study of ‘VTP-43742’ in psoriatic patients. The lead drug candidate VTP-43742 is company’s wholly owned, orally active and first-in-class RORγt inhibitor with strong potential to transform the cure of multiple autoimmune disorders. It is done by blocking the mechanism of IL-23 and the powerful inhibition of IL-17 discharge from Th17 cells.
Vitae’s randomized, placebo-controlled, double-blind study assessed the tolerability, efficacy, safety, pharmacodynamics and pharmacokinetics of multiple oral regimen of VTP-43742 in patients suffering with psoriasis for a four-week period. The drug VTP-43742 displayed a clear indication of efficacy, with enrollments in the 350 mg regimen group showing a 24% decline in the Psoriasis Area Severity Index score relative to placebo. Coming to the 700 mg regimen group, patients showed a 30% decline in placebo-adjusted PASI score. For both doses, Vitae observed statistically significant and clinically reductions relative to baseline values.
The expert speak
Jeff Hatfield, the President and CEO of Vitae, said that they believe the latest results validate RORγt as an innovative and exciting therapeutic target for the cure of psoriasis and other autoimmune problems. In current scenario the autoimmune market is led by injectable antibody treatments. Still, the company believes that VTP-43742 boasts strong prospects to expand utilization of oral treatments in many autoimmune disorders, including rheumatoid arthritis, psoriasis, psoriatic arthritis, inflammatory bowel disease and multiple sclerosis with a safe, well tolerated, and effective once-a-day agent.
The future plans
In biomarker assays determining plasma IL-17F and IL-17A, the 700 mg and 350 mg regimen of ‘VTP-43742’ were shown to reduce both plasma cytokines up to 75%, and these declines were statistically significant, consistent with the variation in PASI score compared to baseline. Dr. Richard Gregg, the CSO of Vitae, said that they plan to develop VTP-43742 treatment into a 16 week study in the second half of this year to continue to evaluate the tolerability, efficacy and safety of first-in-class drug candidate.