2009.07.30 – Incyte Provides Update on Drug Development Programs

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2009.07.30 – Incyte Provides Update on Drug Development Programs

Posted : Thu, 30 Jul 2009 11:02:38 GMT
Author : Incyte Corporation

WILMINGTON, Del. – (Business Wire) Incyte Corporation (Nasdaq:INCY) today reported second quarter 2009 financial results and provided an update on its highest priority clinical programs.

“With the Phase III registration trials for our lead JAK1/JAK2 inhibitor, INCB18424, now underway in both the U.S. and Europe; the launch of a six-month Phase II trial for our second JAK1/JAK2 inhibitor, INCB28050, in rheumatoid arthritis; the release of positive Phase IIb results for our 11beta-HSD1 inhibitor for type 2 diabetes; and the expected release of Phase IIb results for topical INCB18424 in psoriasis later this summer, we have made substantial progress building our pipeline. I believe we are in a strong position to create and capture value from these programs both on our own and through strategic partnerships,” stated Paul A. Friedman, M.D., Incyte’s President and Chief Executive Officer.

Below is a summary of recent developments for our most advanced product candidates:

Janus Kinase (JAK) Inhibitor Program

INCB18424: (oral formulation) Myelofibrosis, Polycythemia Vera and Essential Thrombocythemia

  • Agreement reached with the U.S. Food and Drug Administration (FDA) for a Special Protocol Assessment (SPA) for INCB18424 as a treatment in myelofibrosis (MF).
  • Announcement that the Phase III trial under the SPA, COMFORT-I, is expected to begin patient enrollment in August and involve 240 patients with primary myelofibrosis (PMF), post polycythemia vera myelofibrosis (PPV-MF) and post essential thrombocythemia myelofibrosis (PET-MF). COMFORT-I is scheduled to include over 90 clinical sites in the U.S., Canada and Australia.
  • Initiation of a second Phase III trial, COMFORT-II, in Europe began enrolling patients in July and is expected to enroll 150 patients in approximately 70 clinical sites.

INCB18424: (topical formulation) Psoriasis and Other Inflammatory Conditions of the Skin

  • Completed a three-month multiple-dose Phase IIb trial in patients with mild to moderate psoriasis. Results from this trial are expected later this summer.

INCB28050: JAK Inhibitor Compound for Rheumatoid Arthritis and Other Inflammatory Conditions

  • Initiated a six-month double-blind placebo-controlled dose-ranging Phase II trial that is scheduled to include 100 patients with active rheumatoid arthritis who have had inadequate response to currently available disease modifying therapies.

11beta-HSD1 Inhibitor Program

INCB13739: Type 2 Diabetes

  • Presented clinical results at the American Diabetes Association 69th Scientific Sessions from a 3-month placebo-controlled, dose-ranging Phase IIb trial involving over 300 patients with type 2 diabetes which demonstrated that treatment with once-daily doses of INCB13739 significantly improved glycemic control, as measured by hemoglobin A1c, insulin sensitivity and total-cholesterol levels.

Sheddase Inhibitor Program

INCB7839: Breast Cancer

  • Continued enrollment of a Phase II trial in combination with Herceptin(R) in breast cancer patients. We expect to present results from this trial at the San Antonio Breast Cancer Symposium in December 2009.