2009.09.21 – Incyte Announces Positive Top-Line Phase IIb Results for Topical INCB18424 in Psoriasis
Incyte Announces Positive Top-Line Phase IIb Results for Topical INCB18424 in Psoriasis
WILMINGTON, Del.–(BUSINESS WIRE)–Incyte Corporation (Nasdaq:INCY) announced positive clinical trial results for a topical formulation of its lead janus kinase (JAK) inhibitor, INCB18424, in psoriasis. These results were obtained from a multi-center three-month Phase IIb trial comparing three once-daily doses of topical INCB18424 to vehicle in 200 patients with mild-to-moderate psoriasis. In the trial patients treated with INCB18424 had a statistically significant improvement over placebo in the reduction in total lesion score (erythema + scaling + thickness), which was the primary efficacy endpoint of the trial. Statistical significance was also achieved for the secondary endpoints: the Physician Global Assessment score and the Psoriasis Area and Severity Index score. INCB18424 was well tolerated at all doses and no clinically significant effects were noted in hematology or other laboratory parameters.
Paul Friedman, M.D., Incyte’s President and CEO, will review these top-line clinical trial results during his corporate presentation at 12:00 pm (ET) today at the 2009 UBS Global Life Sciences Conference.
Dr. Friedman stated, “Our JAK1/JAK2 inhibitor was designed to block signaling from multiple key cytokines implicated in psoriasis and it is gratifying to see that topical INCB18424 met the primary and secondary endpoints in this three-month Phase IIb trial. We believe the positive safety and efficacy results achieved with this new mechanism of action have the potential to differentiate topical INCB18424 from the topical corticosteroids and vitamin D analogues which are limited by their duration of use and/or their tolerability profile.”
Incyte intends to present full results from this Phase IIb trial at an appropriate future scientific meeting.
To access today’s presentation at the UBS conference, please go to www.incyte.com under Investor Relations, Events and Webcasts. Investors interested in listening to the live webcast should log on before the start time in order to download any software required. A replay of the presentation will also be available.
Incyte Corporation is a Wilmington, Delaware-based drug discovery and development company focused on developing proprietary small molecule drugs for oncology, inflammation and diabetes. Incyte’s most advanced compound, INCB18424, is in Phase III development for myelofibrosis. For additional information on Incyte, visit the Company’s web site at www.incyte.com.
Forward Looking Statements
Except for the historical information contained herein, the matters set forth in this press release, including statements with respect to the potential to differentiate topical INCB18424 from the topical corticosteroids and vitamin D analogues, are all 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 subject to risks and uncertainties that may cause actual results to differ materially, including the high degree of risk associated with drug development and clinical trials, the potential failure of topical INCB18424 to differentiate from topical corticosteroids and vitamin D analogues, uncertainties regarding the therapeutic and commercial value of topical INCB18424 due to its early stage in clinical trials, the results of further research and development, the impact of competition and of technological advances and the ability of Incyte to compete against parties with greater financial or other resources, Incyte’s ability to enroll a sufficient number of patients for its clinical trials, 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, 2009. Incyte disclaims any intent or obligation to update these forward-looking statements.