ISTANBUL--(BUSINESS WIRE)--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).
Exploratory efficacy analyses suggested that efficacy was approximately equal in patients with greater than 10 percent body surface area involvement and in patients with 5 to 10 percent body surface area involvement prior to treatment.
The compound was generally well-tolerated with no evidence of myelosuppression. Decreases in platelet counts were observed, but the counts generally remained within normal limits. Increases in LDL and HDL were also noted without a significant change in the HDL/LDL ratio.
To access the presentation: INCB39110 EADV Presentation
“Our proof-of-concept studies of INCB39110 in psoriasis, rheumatoid arthritis and myelofibrosis are providing us with greater insight and confirm our belief that JAK1 inhibition may be of benefit in chronic inflammatory disorders as well as oncologic indications,” stated Richard S. Levy, Incyte’s Executive Vice President and Chief Drug Development and Medical Officer. “With our portfolio of JAK1 inhibitors, we’re well-positioned to potentially pursue development in chronic inflammatory conditions and oncology with separate molecules, as we did with our JAK1/JAK2 inhibitor program.”
INCB39110 is the most advanced compound within Incyte’s portfolio of selective JAK1 inhibitors and is being evaluated in Phase II proof-of-concept trials in psoriasis, rheumatoid arthritis and myelofibrosis and an initial Phase I/II safety study in combination with gemcitabine and nab-paclitaxel in patients with advanced solid tumors to help define its clinical efficacy and safety profile, understand potential points of differentiation between JAK1 and JAK1/JAK2 inhibition and determine the most appropriate path forward for further development.
Incyte Corporation is a Wilmington, Delaware-based biopharmaceutical company focused on the discovery, development and commercialization of proprietary small molecule drugs for oncology and inflammation. For additional information on Incyte, please visit the Company's website at www.incyte.com.
Except for the historical information set forth herein, the matters set forth in this press release, including without limitation statements with respect to the potential efficacy and safety and therapeutic potential of INCB39110, our belief that JAK1 inhibition may be of benefit in chronic inflammatory disorders as well as oncologic indications, and our potential to pursue development in chronic inflammatory conditions and oncology with separate JAK1 inhibitor molecules, contain predictions and estimates and are forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on Incyte’s current expectations and subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments in and risks related to the efficacy or safety of INCB39110, the results of further research and development, other market, economic or strategic factors and technological advances, and other risks detailed from time to time in Incyte's filings with the Securities and Exchange Commission, including its Quarterly Report on Form 10-Q for the quarter ended June 30, 2013. Incyte disclaims any intent or obligation to update these forward-looking statements.