BioCryst Expands Development of BCX7353 to Explore Treatment of Acute HAE Attacks
April 12 2017 - 6:45AM
BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX), a pharmaceutical
company focused on the development and commercialization of
treatments for rare diseases, announced today plans to explore a
new oral liquid formulation of BCX7353 for the treatment of acute
attacks in patients with hereditary angioedema (HAE). The
Company has received initial regulatory approvals in Europe to
initiate the ZENITH-1 exploratory clinical trial this summer.
“To complement the attractive profile of our
prophylactic treatment program, as evidenced by the interim results
from our APeX-1 trial, we made a decision to explore an additional
indication for the treatment of acute attacks with a new oral
liquid formulation. The rapid absorption and long half-life
of BCX7353 observed after single oral doses in healthy volunteers,
and the strong encouragement from disease experts and patient
advocates have motivated us to explore ‘7353 as an acute
treatment,” said Jon Stonehouse, Chief Executive Officer. “We
believe this new formulation can fill an unmet need for patients
with less frequent attacks who are looking for better ways to
manage their illness. This initiative has the potential to provide
patients with a more convenient option for the treatment of acute
attacks, and if successful, the first oral acute therapy for
HAE.”
The purpose of ZENITH-1 is to explore whether
single oral doses of a liquid formulation of BCX7353 could have
utility in the treatment of acute angioedema attacks in patients
with hereditary angioedema. It is designed as a randomized,
double-blind, placebo controlled, dose-ranging trial with BCX7353
self-administered at home to treat attacks. Additional information
and clinical trial design will be provided upon completion of the
regulatory process and trial initiation.
About BCX7353
Discovered by BioCryst, BCX7353 is a novel,
once-daily, selective inhibitor of plasma kallikrein currently in
development for the prevention of angioedema attacks in patients
diagnosed with HAE. With the initiation of the ZENITH-1 clinical
trial, the oral liquid formulation of BCX7353 will be evaluated for
treating acute angioedema attacks. BCX7353 has been generally safe
and well tolerated in the ongoing Phase 2 ApeX-1 clinical trial and
in clinical pharmacology studies in healthy volunteers.
About BioCryst Pharmaceuticals
BioCryst Pharmaceuticals designs, optimizes and
develops novel small molecule drugs that block key enzymes involved
in rare diseases. BioCryst has several ongoing development
programs: BCX7353 and other second generation oral inhibitors of
plasma kallikrein for hereditary angioedema, and galidesivir, a
broad spectrum viral RNA polymerase inhibitor that is a potential
treatment for filoviruses. RAPIVAB® (peramivir injection), a viral
neuraminidase inhibitor for the treatment of influenza, is
BioCryst's first approved product and has received regulatory
approval in the U.S., Canada, Japan, Taiwan and Korea.
Post-marketing commitment development activities for RAPIVAB are
ongoing, as well as activities to support regulatory approvals in
other territories. 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: developing any HAE drug candidate may
take longer or may be more expensive than planned; ongoing and
future preclinical and clinical development of HAE second
generation drug candidates (including APeX-1 and ZENITH-1) may not
have positive results; that BioCryst may not be able to enroll the
required number of subjects in planned clinical trials of product
candidates; that the Company may not advance human clinical trials
with product candidates as expected; 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 BioCryst may not
receive additional government funding to further support the
development of galidesivir; that galidesivir development may not be
successful; that BARDA and/or NIAID may further condition, reduce
or eliminate future funding; that revenue from peramivir injection
is unpredictable and may never result in significant revenue for
the Company; that the Company may not be able to continue
development of ongoing and future development programs; that such
development programs may never result in future products; that
actual financial results may not be consistent with expectations,
including that 2017 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
CONTACT: Robert Bennett, BioCryst Pharmaceuticals, +1-919-859-7910
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