Incyte Corporation (Nasdaq: INCY) announced results from a 28-day, placebo-controlled, dose-escalation Phase II proof-of-concept clinical trial involving 50 patients with chronic plaque psoriasis for its proprietary oral JAK1 inhibitor, INCB39110. The results were presented by Robert Bissonnette, M.D., President of Innovaderm Research Inc. and co-lead investigator, today at the European Academy of Dermatology and Venereology (EADV) Congress in Istanbul, Turkey.
In the trial, evidence of efficacy was observed in patients treated with INCB39110 at all doses as measured by static physician global assessment (sPGA) and psoriasis area and severity index (PASI) as compared to patients treated with placebo. INCB39110 was generally well-tolerated with no evidence of myelosuppression.
Dr. Bissonnette stated, “These initial results with INCB39110 are encouraging and demonstrate the agent’s anti-inflammatory activity and the therapeutic potential of JAK1 inhibition in psoriasis.”
Summary of Study Results
The results of the Phase II clinical trial were reported during an oral presentation,
A Double-Blind, Placebo-Controlled Study Exploring the Safety, Tolerability, and Efficacy of a 28-Day Course of Escalating Doses of an Oral JAK1 Inhibitor in Subjects with Stable, Chronic Plaque Psoriasis
. The trial evaluated four doses of INCB39110, specifically 100 mg once daily, 200 mg once daily, 200 mg twice daily and 600 mg once daily.
The primary endpoint of the study was the mean percent change from baseline in sPGA score at Day 28, and the secondary endpoints were the percentage of patients achieving sPGA 0 or 1 (clear or minimal) and the percentage of patients achieving PASI 50.
The study demonstrated evidence of efficacy as assessed by sPGA at all doses (ranging from -22.2% to -42.4% mean change in sPGA) as compared to placebo (-12.5% mean change in sPGA). The data also showed efficacy in terms of the percentage of patients who achieved clear or almost clear sPGA (ranging from 11.1% to 45.5% for all doses of INCB39110 vs. 0% for placebo) and PASI 50 (ranging from 22.2% to 81.8% for all doses of INCB39110 vs. 8.3% for placebo).