RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--
BioCryst
Pharmaceuticals, Inc. (NASDAQ:BCRX) today announced that the National
Institute of Allergy and Infectious Diseases (NIAID) has exercised
an option to conduct the investigational new drug (IND) enabling program
and to submit an IND. This option represents an additional $2.5 million
to BioCryst in order to advance the development of BCX4430
as a treatment for Marburg virus disease. NIAID, part of the National
Institutes of Health, granted an initial award of $5.0 million to
BioCryst in September 2013. The total funding could be up to $22.0
million over five years and advance the program through Phase 1 trials,
if all contract options are exercised.
"With these additional funds, BioCryst will rapidly initiate
IND-enabling studies of intramuscular BCX4430," said Dr.
William P. Sheridan, Chief Medical Officer at BioCryst. "This is an
important next step in moving the development program forward to an IND
submission, leading to an initial safety trial in healthy human
volunteers."
The goals of this contract are to file IND applications for intravenous
and intramuscular BCX4430 for the treatment of Marburg virus disease,
and to conduct Phase 1 human clinical trials.
This project will be funded in whole or in part with Federal funds from
the National Institute of Allergy and Infectious Diseases, National
Institutes of Health, Department of Health and Human Services, under
Contract No. HHSN272201300017C.
About the BSAV Program & BCX4430
The objective of BioCryst's BSAV research program is to develop
broad-spectrum parenteral and oral therapeutics for viruses that pose a
threat to health and national security. The lead BSAV compound is
BCX4430, an RNA dependent-RNA polymerase inhibitor that has demonstrated
broad-spectrum activity for multiple viruses and a favorable preliminary
preclinical safety profile. BioCryst is developing BCX4430 in
collaboration with U.S. Government Agencies following the Animal Rule
regulatory pathway.
About BioCryst Pharmaceuticals
BioCryst Pharmaceuticals designs, optimizes and develops novel small
molecule drugs that block key enzymes involved in infectious and rare
diseases, with the goal of addressing unmet medical needs of patients
and physicians. BioCryst's core development programs include BCX4161 and
two next generation oral inhibitors of plasma kallikrein for hereditary
angioedema; peramivir,
a viral neuraminidase inhibitor for the treatment of influenza; and BCX4430,
a broad spectrum antiviral for hemorrhagic fevers. 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 BioCryst's 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 are 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 BioCryst or its licensees may not be able to enroll the required
number of subjects in planned clinical trials of its product candidates
and that such clinical trials, may not be successfully completed; that
the Company or its licensees may not commence as expected additional
pre-clinical studies or human clinical trials may not be commenced as
expected or such studies may not be successfully completed; that the FDA
may require additional studies beyond the studies planned for product
candidates, or may not provide regulatory clearances which may result in
delay of planned clinical trials, or may impose a clinical hold with
respect to such product candidate, or withhold market approval for
product candidates; that the Company may not be able to obtain
additional funding for BCX4430; that government funding or other
contracts for BCX4430 may have certain terms and conditions, including
termination provisions, that subject the Company to additional risks;
that the Company may lose current funding for the program; that the
Company may not be able to continue development of BCX4430 for any
number of reasons; that the Company may never file an IND for BCX4430;
that any product, including peramivir may never be approved for any use
by the FDA; that ongoing and future preclinical and clinical development
may not have positive results; that the Company or its licensees may not
be able to continue development of ongoing and future development
programs; that such development programs may never result in future
product, license or royalty payments being received; that the Company
may not be able to retain its current pharmaceutical and biotechnology
partners for further development of its product candidates or may not
reach favorable agreements with potential pharmaceutical and
biotechnology partners for further development of product candidates,
including ulodesine; that its actual financial results may not be
consistent with its expectations, including that 2013 operating expenses
and cash usage may not be within management's expected ranges. 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
BioCryst's projections and forward-looking statements.
BCRXW
BioCryst Pharmaceuticals
Robert Bennett, +1-919-859-7910
Source: BioCryst Pharmaceuticals, Inc.
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