| [February 15, 2012] |
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BioCryst Announces Promising Results from Preclinical Studies of BCX5191 for Hepatitis C
RESEARCH TRIANGLE PARK, N.C. --(Business Wire)--
BioCryst
Pharmaceuticals, Inc. (NASDAQ: BCRX) today announced favorable
preclinical results for BCX5191, a novel adenine nucleoside analog
targeting viral RNA polymerase for the potential treatment of hepatitis
C.
BioCryst has successfully completed in vitro and in vivo
studies in which BCX5191 exhibited potent and selective pan-genotypic
antiviral activity against the hepatitis C polymerase enzyme. BCX5191
showed no inhibition of human RNA polymerase and no evidence of toxicity
from standard in vitro screens.
Human liver cells rapidly and efficiently convert BCX5191 into its
active triphosphate form. BCX5191 does not require prodrug technology to
achieve bioavailability. BCX5191 inhibits the viral RNA polymerase
enzyme across genotypes 1-4 at sub-micromolar concentrations (0.05-0.36
µM) and is active in replicon cell assays for genotypes 1a and 1b.
In preclinical models, BCX5191 demonstrates high oral bioavailability,
and the drug is actively transported into the liver. Following a single
oral dose in rats, liver BCX5191 triphosphate levels exceed the IC50
values for genotypes 1-4 through 24 hours. At Cmax, the drug
triphosphate level is more than 100 times the IC50. This
pharmacokinetic profile is expected to support once-daily dosing in
clinical studies.
"BCX5191 has met stringent preclinical criteria to advance to
IND-enabling studies. We expect this program to be ready to file for
first-in-human studies during the fourth quarter of 2012," said Dr.
William P. Sheridan, Senior Vice President & Chief Medical Officer
of BioCryst Pharmaceuticals. "Based on our internal comparative
preclinical studies of BCX5191 with the most advanced nucleotide analog
in clinical development, GS-7977, we believe BCX5191 has the potential
to be the backbone of best-in-class oral treatment regimens for
hepatitis C patients."
Additional BCX5191 non-clinical experiments are ongoing or planned,
including Good Laboratory Practices (GLP) non-clinical safety studies
and in vitro evaluation of BCX5191 in combination with ribavirin.
Conferece Call and Webcast
BioCryst's leadership team will host a conference call and webcast on
Thursday, February 16, 2012 at 11:00 a.m. Eastern Time to discuss
financial results and recent corporate developments, including results
from the BCX5191 hepatitis C program. To participate in the conference
call, please dial 1-877-303-8027 (United States) or 1-760-536-5165
(International). No passcode is needed for the call. The webcast and
accompanying slides can be accessed by logging onto www.BioCryst.com.
Accompanying slides will be available on the BioCryst website several
hours prior to the call. Please connect to the website at least 15
minutes prior to the start of the conference call to ensure adequate
time for any software download that may be necessary.
About Hepatitis C
Hepatitis C is a contagious liver disease that results from infection
with the hepatitis C virus (HCV), which is the most common virus that
infects the liver and can lead to life-threatening liver problems, such
as liver damage, cirrhosis, liver failure or liver cancer. There are an
estimated 170 million individuals worldwide who are chronically infected
with HCV, and about 3 to 4 million people are infected annually. In the
United States, there are approximately 4 million people who have chronic
hepatitis C.
About BioCryst
BioCryst Pharmaceuticals designs, optimizes and develops novel
small-molecule pharmaceuticals that block key enzymes involved in
infectious diseases, inflammatory diseases and cancer. BioCryst
currently has three novel late-stage compounds in development: peramivir,
a neuraminidase inhibitor for the treatment of influenza, BCX4208, a
purine nucleoside phosphorylase (PNP) inhibitor for the treatment of
gout, and forodesine, an orally-available PNP inhibitor for cancer,
which is being developed by Mundipharma under a global license
agreement. Utilizing crystallography and structure-guided drug design,
BioCryst continues to discover additional compounds and to progress
others through preclinical and early development to address the unmet
medical needs of patients and physicians. For more information, please
visit the Company's website 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 there can be
no assurance that our compounds will prove effective in clinical
studies; that development and commercialization of our compounds may not
be successful; 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 BioCryst or its licensees may not commence as expected
human clinical trials with BCX5191; that ongoing and future preclinical
and clinical development 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 reach favorable agreements with
potential pharmaceutical and biotechnology partners for further
development of BCX5191; that our actual cash burn rate may not be
consistent with our expectations; 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

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