Results from Incyte's (INCY) Oral 11beta-HSD1 Inhibitor, INCB13739, Study Presented at ADA
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Incyte Corporation (Nasdaq: INCY) announced over the weekend clinical results of its Phase IIb trial of INCB13739, an orally bioavailable inhibitor of the enzyme 11beta-hydroxysteroid dehydrogenase type 1 (11beta-HSD1), at the American Diabetes Association 69th Scientific Sessions being held in New Orleans.
Results from this double-blind, placebo-controlled Phase IIb trial involving over 300 patients with type 2 diabetes showed that treatment with once-daily doses of INCB13739 significantly improved glycemic control, as measured by hemoglobin A1c (HbA1c), insulin sensitivity and total-cholesterol levels. These results will be described by the principal investigator for the trial, Julio Rosenstock, M.D., of the Dallas Diabetes and Endocrine Center at Medical City and Clinical Professor of Medicine at University of Texas Southwestern Medical School, on Sunday from noon to 2 p.m. CT during a late breaker poster session entitled, "Clinical Therapeutics/New Technology - Pharmacologic Treatment of Diabetes or its Complications." The poster is currently available at: http://phx.corporate-ir.net/External.File?item=UGFyZW50SUQ9NzkwNHxDaGlsZElEPS0xfFR5cGU9Mw==&t=1
Summary of Phase IIb Results
- Twelve weeks of 100 mg and 200 mg once-daily INCB13739 added to failing metformin monotherapy in patients with type 2 diabetes resulted in a statistically significant placebo-adjusted reduction in HbA1c of -0.47 and -0.56% respectively.
- Patients receiving 200 mg INCB13739 achieved a statistically significant reduction in fasting plasma glucose, homeostasis model assessment-estimated-insulin resistance and total cholesterol.
- Normal cortisol levels and rhythmicity were maintained by the expected compensatory adrenocorticotropic hormone (ACTH) response following INCB13739 treatment. ACTH plateaued at week 4 and returned to baseline after cessation of therapy.
- Dehydroepiandrosterone and A4 levels increased in concert with ACTH. Levels plateaued after 4 weeks, reversed after cessation of therapy, and were not associated with increased testosterone or suppression of androgenic target proteins.
- INCB13739 was well tolerated at all dose levels.
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