Incyte to Report Positive Clinical Results from JAK Inhibitor and 11beta-HSD1 Inhibitor Programs and Introduce New Metabolic Program at JPMorgan Healthcare Conference
A Live and Archived Copy of the Presentation Will Be Available on Incyte's Website on January 8, 2008
JPMorgan 26th Annual Healthcare Conference
WILMINGTON, Del. -- Incyte Corporation (Nasdaq:INCY) will announce today at the 26th Annual JPMorgan Healthcare Conference further positive clinical proof-of-concept results for several of its wholly-owned, internally developed programs, including its JAK inhibitor for rheumatoid arthritis, myelofibrosis and psoriasis, as well as its 11-beta hydroxysteroid dehydrogenase type 1 (11beta-HSD1) inhibitor for type 2 diabetes. During the JPMorgan presentation, the Company will also introduce its HM74a agonist program for type 2 diabetes and review the key objectives for all its lead programs in 2008.
JAK Inhibitor Program
Incyte will report, for the first time, positive preliminary results obtained from an ongoing 28-day Phase IIa placebo-controlled dose-ranging trial with its lead oral JAK inhibitor, INCB18424, in rheumatoid arthritis (RA).
Paul Friedman, M.D., Incyteâ€™s President and CEO, stated, â€œAlthough we have limited data, the early results we are seeing with our orally administered JAK inhibitor in RA patients are quite remarkable. Three of four patients completing the 28-day study have achieved ACR50 criteria, two of whom also met ACR90 criteria, one within two weeks. As expected the two patients receiving placebo have not shown significant responses. While it is too soon to compare response rates with other therapies, these early results with our orally administered therapy appear at least equal, and possibly superior, to those seen with the intravenously and intramuscularly-administered biologics, such as the anti-TNF agents or the anti-IL-6 receptor antibody. Importantly, all patients have tolerated the drug extremely well at the current dose of 15 mg BID.â€
Incyte will also describe further positive clinical results from the ongoing Phase Ib/IIa trial of INCB18424 in myelofibrosis, a serious neoplastic condition characterized by bone marrow failure, life-threatening splenic enlargement, and marked constitutional symptoms, causing patients a significant loss in quality of life.
â€œAs reported at the American Society of Hematology Meeting, the clinical efficacy we have seen with INCB18424 in the first eleven myelofibrosis patients treated in this study is impressive and unprecedented. We are now seeing the same dramatic results in the expanded cohort of 21 additional patients, at the well-tolerated dose of 25 mg BID. We look forward to meeting with representatives from the U.S. Food and Drug Administration to define the potential registration pathway for INCB18424 as a treatment for myelofibrosis,â€ stated Dr. Friedman.
Incyte will also describe additional results from a 28-day Phase IIa trial with the topical form of INCB18424 in mild-to-moderate psoriasis patients, where INCB18424 provides at least comparable efficacy to the potent topical steroid, DiproleneÂ®. INCB18424 continues to be extremely well-tolerated in this study and, assuming it continues to be so in the ongoing required safety studies, Incyte intends to begin a three-month psoriasis Phase IIb trial in the second half of 2008.
11beta-HSD1 Inhibitor Program
For Incyteâ€™s oral 11beta-HSD1 inhibitor, INCB13739, Incyte will also report further data from the Phase IIa 28-day hyperinsulinemic clamp study in type 2 diabetics. This study is now fully enrolled and a preliminary analysis has been completed.
Dr. Friedman stated, â€œDespite the short duration of this study, we have seen improvements in six different measures of glucose control and cardiovascular risk, including fasting plasma glucose, LDL cholesterol, total cholesterol, triglycerides, clamp-measured liver glucose production, and clamp-measured peripheral glucose uptake. Based on these results, as well as the extremely clean safety profile we have seen with INCB13739, we plan to initiate a 3-month Phase IIb study in type 2 diabetics in the March-April timeframe.â€
The Phase IIb study will evaluate multiple once-daily doses of INCB13739, administered in combination with metformin, in subjects with poorly controlled hyperglycemia. In addition to measuring hemoglobin A1c, this study will assess a range of cardiovascular risk factors to begin to differentiate the compound from currently available therapies directed toward insulin resistance.
HM74a Agonist Program
Incyte will also introduce its HM74a agonist program. HM74a is the receptor to which niacin binds and activates, resulting in a reduction in plasma free fatty acid levels. High free fatty acid levels have been shown to cause insulin resistance and hyperglycemia, and while substantial clinical data support the potential for HM74a agonism to provide therapeutic benefit in type 2 diabetes, the currently available HM74a agonist â€“ niacin â€“ in its various formulations is not used primarily because its short duration of activity does not allow for effective and sustained lowering of free fatty acid levels. In addition, niacin causes cutaneous flushing which is often poorly tolerated. Our lead HM74a agonist, INCB19602, has now completed a single-dose Phase I trial, in which low and well tolerated doses dramatically reduced free fatty acid levels in an effective and sustained fashion and did not cause any cutaneous flushing. Provided the compound successfully completes the ongoing multiple-dose Phase I trial, Incyte plans to initiate a Phase IIa trial in type 2 diabetic patients in the first half of 2008.