BIRMINGHAM, Ala.–(Business Wire)–
BioCryst Pharmaceuticals, Inc. (NASDAQ: BCRX) today announced it is initiating a
Phase 2 study of BCX4208 alone and in combination with allopurinol in patients
with gout. BioCryst recently reported positive results from part one of its
Phase 2 monotherapy study of BCX4208 in patients with gout and is now moving
forward as planned with an additional Phase 2 trial of BCX4208.
This randomized, double-blind, multi-center, placebo-controlled study is
designed to evaluate the urate-lowering activity and safety of several doses of
BCX4208 alone and in combination with selected doses of allopurinol administered
once-daily in patients with gout for 21 days. The enrollment target for this
study is approximately 80 patients. The study utilizes a factorial design,
evaluating BCX4208 at doses of 20 mg, 40 mg and 80 mg administered as
monotherapy or in combination with allopurinol at doses of 100 mg, 200 mg and
300 mg. Allopurinol administered at 300 mg is the most common treatment dose for
patients with gout. The doses of BCX4208 selected for this study have been found
to be generally safe and well-tolerated in patients with psoriasis or gout.
Further details regarding this Phase 2 study design is available at
clinicaltrials.gov at the following link:
http://clinicaltrials.gov/ct2/show/NCT01129648
“We are pleased to initiate this Phase 2 study of BCX4208, a highly potent and
selective PNP inhibitor, as it will help to determine whether the inhibition of
xanthine oxidase and PNP together has additive or synergistic effects in
reducing uric acid levels in patients with gout,” said Dr. William P. Sheridan,
Chief Medical Officer at BioCryst. “We expect to complete this study during 2010
and look forward to providing top-line data in the fourth quarter.”
About BCX4208
BCX4208 is a next generation purine nucleoside phosphorylase (PNP) inhibitor
with the potential for once-a-day dosing suitable for chronic administration.
Previous studies have shown that BCX4208 may have utility in diseases dependent
on T-cells, B-cells or uric acid. With its novel mechanism of action, BCX4208
has the potential to address unmet medical needs across a broad spectrum of
inflammatory diseases, including gout.
About Gout
Gout is an inflammatory arthritis that affects up to five million people in the
U.S. Gout is caused by higher-than-normal uric acid in the blood, (a condition
known as hyperuricemia) that may lead to the buildup of uric acid in synovial
fluid around joints and the formation of monosodium urate crystals that result
in painful joint inflammation. More information regarding gout and hyperuricemia
is available at: http://www.cdc.gov/arthritis/basics/gout.htm
About BioCryst
BioCryst Pharmaceuticals designs, optimizes and develops novel small-molecule
pharmaceuticals that block key enzymes involved in infectious diseases, cancer
and inflammatory diseases. BioCryst has progressed two novel compounds that are
in late-stage pivotal clinical trials; peramivir, an anti-viral for influenza,
and forodesine, a purine nucleoside phosphorylase (PNP) inhibitor forcutaneous
T-cell lymphoma (CTCL). Additionally, BioCryst has a third product candidate,
BCX4208-a next generation PNP inhibitor-in mid-stage trials for the treatment of
gout. Utilizing crystallography and structure-based drug design, BioCryst
continues to discover additional compounds and to progress others through
pre-clinical and early development to address the unmet medical needs of
patients and physicians. For more information, please visit the Company’s Web
site at www.biocryst.com.
Forward-Looking Statements
This press release contains forward-looking statements, including statements
regarding future results, performance or achievements. These statements involve
known and unknown risks, uncertainties and other factors which may cause our
actual results, performance or achievements to be materially different from any
future results, performances or achievements expressed or implied by the
forward-looking statements. These statements reflect our current views with
respect to future events and are based on assumptions and subject to risks and
uncertainties. Given these uncertainties, you should not place undue reliance on
these forward-looking statements. Some of the factors that could affect the
forward-looking statements contained herein include: that we or our licensees
may not be able to enroll the required number of subjects in planned clinical
trials of our product candidates and that such clinical trials may not be
successfully completed; that our product candidates may not receive required
regulatory clearances from the FDA; that ongoing and future preclinical or
clinical development and commercialization of our product candidates, including
peramivir, forodesine, BCX4208 and other PNP inhibitor and hepatitis C
development programs, may not have positive results; that we or our licensees
may not be able to continue future development of our current and future
development programs; that our development programs may never result in future
product, license or royalty payments being received by BioCryst; that BioCryst
may not be able to retain its current pharmaceutical and biotechnology partners
for further development of its product candidates or it may not reach favorable
agreements with potential pharmaceutical and biotechnology partners for further
development of its product candidates; that BioCryst may not have sufficient
cash to continue funding the development, manufacturing, marketing or
distribution of its products and that additional funding, if necessary, may not
be available at all or on terms acceptable to BioCryst. Please refer to the
documents BioCryst files periodically with the Securities and Exchange
Commission, specifically BioCryst’s most recent Annual Report on Form 10-K,
Quarterly Reports on Form 10-Q, and current reports on Form 8-K, all of which
identify important factors that could cause the actual results to differ
materially from those contained in our projections and forward-looking
statements.
BCRXW
BioCryst Pharmaceuticals
Robert Bennett, +1-919-859-7910
or
WeissComm Group
Catherine Collier Kyroulis, +1-212-301-7174 (Media)
Copyright Business Wire 2010