Incyte to Report Positive Clinical Results from JAK Inhibitor and 11beta-HSD1 Inhibitor...

Tue Jan 8, 2008 8:00am EST
 
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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, Beginning at 9:30 am PT/12:30 pm
                                  ET
WILMINGTON, Del.--(Business Wire)--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., Incyte's President and CEO, stated, "Although
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."

   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.

   "As 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," 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, Diprolene(R). 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 Incyte'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, "Despite 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."

   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 - niacin - 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.

   2008 Clinical Objectives

   In his presentation at the JPMorgan Conference, Dr. Friedman will
also highlight key clinical objectives for 2008 including:

   JAK Inhibitor Program

   INCB18424

   --  Complete discussions with the FDA regarding a registration
        strategy for the myelofibrosis indication and initiate Phase
        II/III trials in the second half of 2008

   --  Initiate a three-month Phase IIb oral rheumatoid arthritis
        trial in the second half of 2008

   --  Initiate a 28-day Phase IIa oral trial in psoriasis in the
        first half of 2008

   --  Initiate a Phase IIb topical trial in psoriasis in the second
        half of 2008

   --  Initiate a Phase II trial in polycythemia vera and essential
        thrombocytemia patients in the first half of 2008

   INCB28050

   Complete preclinical safety and initiate Phase I trials in
mid-2008

   11beta-HSD1 Inhibitor Program

   INCB13739

   --  Initiate the three-month Phase IIb trial in type 2 diabetes in
        the first half of 2008

   --  Present the 28-day Phase IIa trial results in a scientific
        forum

   INCB20817

   --  Initiate and complete Phase I trials in the first half of 2008

   HM74a Agonist Program

   INCB19602

   --  Initiate Phase IIa trial in the first half of 2008

   CCR5 Inhibitor Program

   INCB9471

   --  Initiate Phase IIb trial in the first half of 2008

   Sheddase Inhibitor Program

   INCB7839

   --  Complete and report results for two Phase II breast cancer
        trials in the second half of 2008 and early 2009 - the first
        trial is in combination with Herceptin(R) and the second is a
        monotherapy trial

   CCR2 Antagonist Program

   INCB8696

   --  Complete Phase I trial in healthy volunteers to support
        development as a treatment for multiple sclerosis

   Discovery

   --  Advance two additional compounds from two new oncology
        programs through IND-enabling studies and into Phase I
        development, progress additional follow-on compounds in
        several of the lead clinical programs, and continue to
        identify and progress new molecular entities, targeted to
        clinically relevant targets

   The Incyte presentation at the JPMorgan Healthcare Conference will
be webcast live today at 12:30 pm Eastern Time / 9:30 am Pacific Time
and can be accessed at www.incyte.com under Investor Relations, Events
and Webcasts. A replay of the presentation will be available for 30
days. Investors interested in listening to the live webcast should log
on before the start time in order to download any required software.

   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 presenting positive clinical proof of concept results for
its JAK inhibitor, INCB18424, in RA, myelofibrosis and psoriasis, as
well as its 11-beta HSD1 inhibitor INCB13739, and introducing its
HM74A program and reviewing key objectives for its lead programs for
2008, the effects of emerging data on those plans, its intention to
begin discussions with the FDA regarding the registration pathway of
INCB18424 as a treatment for myelofibrosis and plans to initiate Phase
II/III trials in the second half of 2008 with INCB18424 in
myelofibrosis, expectations regarding timing of initiation of a 28-day
Phase IIa trial in psoriasis with oral INCB18424, a three-month Phase
IIb trial in RA with oral INCB18424, a Phase IIb trial in psoriasis
with topical INCB18424, a Phase II trial in polycythemia vera and
essential thrombocytopenia with oral INCB18424, Phase I trials for the
follow-on JAK compound INCB28050, a three-month Phase IIb trial for
INCB13739 in type 2 diabetes, Phase I trials for the follow-on 11-beta
HSD1 compound INCB20817, expectations regarding the completion of
Phase I trials for its lead compound in its HM74A program, INCB19602,
as a treatment for type 2 diabetes and expectations regarding the
potential utility of Incyte's HM74A agonists, expectations regarding
the completion and presentation of expected results from two Phase II
breast cancer trials for INCB7839, expectations regarding the timing
of initiation of two Phase IIb studies of INCB9471 in HIV patients,
expectations regarding the timing of expected results from a Phase I
trial of INCB8696 as a treatment for multiple sclerosis, expectations
regarding the advancement of lead compounds from two additional
oncology programs into clinical development and trials, progressing
additional follow-on compounds in several of the lead clinical
programs, and continuing to identify and progress new molecular
entities targeted to clinically relevant targets, 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
uncertainty of the FDA approval process, 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, the
risks associated with Incyte's ability to obtain, maintain and
successfully enforce adequate patent and other intellectual property
protection of its product candidates 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 September 30, 2007. Incyte disclaims any intent or
obligation to update these forward-looking statements.

Incyte Corporation
Pamela M. Murphy
Vice President, Investor Relations/
Corporate Communications
302-498-6944

Copyright Business Wire 2008

 

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