Incyte Reports Positive Proof-of-Concept Results For INCB18424, Its Lead JAK Inhibitor, and INCB13739, its Lead 11beta-HSD1 Inhibitor
-- a completed 28-day dose-escalation Phase Ib/IIa trial in mild-to moderate psoriasis using a topical formulation of INCB18424, its lead janus-associated kinase, JAK, inhibitor;
-- an ongoing dose-escalation Phase Ib/IIa trial in myelofibrosis using the oral formulation of INCB18424; and
-- an ongoing 28-day Phase IIa placebo-controlled two-step hyperinsulinemic clamp trial in Type 2 diabetes for INCB13739, its lead orally available 11beta-HSD1 inhibitor.
Earlier this year, Incyte also announced positive clinical results for its lead CCR5 antagonist that is being developed as a treatment of HIV-1, the retrovirus that causes the acquired immunodeficiency syndrome, AIDS.
Paul A Friedman, M.D., president and CEO of Incyte, stated, "We now have demonstrated clinical proof-of-concept in four of our development programs. As I stated earlier this year, we expected to have proof-of-concept results for multiple indications with our JAK program, and our lead compound, INCB18424 has now shown efficacy in these early studies when administered topically in psoriasis and when administered orally in myelofibrosis. Additional trials using the oral formulation are planned in rheumatoid arthritis, psoriasis, and, potentially, cancers, beyond the myeloproliferative disorders, which means we could have additional proof-of-concept data to report throughout 2008."
Dr. Friedman added, "For INCB13739, our lead 11beta-HSD1 Inhibitor, interim data from our ongoing Phase IIa study in Type 2 diabetes have shown preliminary evidence of a beneficial effect on glycemic control as measured by fasting blood glucose levels as well as encouragingly positive trends in a limited number of patients who have successfully completed the two-step clamp procedures. Importantly, in addition to improving fasting plasma glucose, INCB13739 appears to be having positive effects on risk factors for cardiovascular disease including reduction of LDL, total cholesterol and triglycerides as well as more modest increases in HDL. Provided these positive results continue, we intend to move into a three month Phase IIb trial in type 2 diabetics in the first half of next year."
Dr. Friedman will also provide a brief update on Incyte's other drug discovery and development programs, including:
-- INCB7839, its lead sheddase inhibitor, which is expected to begin Phase II trials in breast cancer patients beginning in November of this year;
-- INCB9471, its lead CCR5 antagonist, which is on track to begin two Phase IIb trials in treatment-experienced HIV patients next year;
-- INCB8696, its lead CCR2 antagonist for multiple sclerosis, which is scheduled to enter Phase I development in October of this year; and
-- three new promising programs, one for metabolic diseases for which the IND has been cleared by the FDA and two for oncology, which are expected to begin clinical development late this year and early in 2008, provided the lead compound from these programs successfully completes IND enabling studies.
To access the webcast of the Incyte presentation at the UBS Global Life Sciences Conference today at 4:30 pm Eastern Time, 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 required software. A replay of the presentation will be available within Events and Webcasts - Past Events http://investor.incyte.com/phoenix.zhtml?c=69764&p=irol-calendar
About Incyte
Incyte is a Wilmington, Delaware-based drug discovery and development company with a growing pipeline of oral compounds to treat HIV, inflammation, cancer and diabetes. 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 expectations of results from proof of concept studies and additional proof of concept studies that should provide further evidence of the potential value of Incyte's JAK program and Incyte's lead 11beta-HSD1 inhibitor INCB13739, the effects of emerging data on those plans, expectations regarding the potential benefits from and initiation of a three-month Phase IIb trial for INCB13739 in type 2 diabetes, expectations regarding the initiation of Phase II trials for INCB7839 in breast cancer, expectations regarding the initiation of two Phase IIb studies of INCB9471 in treatment-experienced HIV patients, expectations regarding the initiation of development of INCB8696 as a treatment for multiple sclerosis, expectations regarding the advancement of lead compounds from additional novel discovery programs into clinical trials, 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, 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, 2007. Incyte disclaims any intent or obligation to update these forward-looking statements.
Contact
Incyte Corporation
Pamela M. Murphy
Vice President
Investor Relations/Corporate Communications
302-498-6944
Posted: September 2007
