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.”
About INCB39110
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.
About Incyte
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.
Forward-Looking Statements
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.
Copyright Business Wire 2013