BioCryst Announces Initiation of the Phase 3 APeX-2 Trial of BCX7353 in Patients with Hereditary Angioedema
March 15 2018 - 6:00AM
BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) announced today the
dosing of the first patient into APeX-2, a Phase 3 clinical trial
evaluating two dosage strengths of BCX7353 administered orally
once-daily (QD) as a preventive treatment to reduce the
frequency of attacks in patients with hereditary angioedema (HAE).
“The ability to safely prevent attacks of angioedema with an
oral medicine has been a dream for many HAE patients. Today
marks a significant milestone toward the realization of that
dream,” said Bruce Zuraw, MD and Principal Investigator of the
APeX-2 trial. “I am excited to be able to participate in this
important trial, which we believe will lead to an effective oral
prophylactic treatment offering HAE patients the opportunity to
lead a normal life.”
APeX-2 is a randomized, double-blind, placebo-controlled,
three-arm trial testing two doses of BCX7353 (110 mg and 150 mg)
for prevention of angioedema attacks. The trial is expected to
enroll approximately 100 patients with Type I and II HAE in the
United States, Canada and Europe. The primary efficacy endpoint of
APeX-2 is the rate of angioedema attacks over 24 weeks of study
drug administration.
"Beginning dosing in the APeX-2 pivotal trial of BCX7353 brings
us one step closer to providing a once-daily, oral prophylactic
treatment to HAE patients. Our entire organization is encouraged
and excited by this important milestone, largely because both
physicians and patients have told us they are waiting for a
convenient and efficacious HAE treatment that allows patients to
lead a more normal life," said Jon Stonehouse, Chief Executive
Officer. “We look forward to reporting top-line results from the
APeX-2 Phase 3 trial in the first half of 2019.”
For more information on the APeX-2 clinical trial, please visit
www.clinicaltrials.gov.
About BCX7353
Discovered by BioCryst, BCX7353 is a novel, oral, once-daily,
selective inhibitor of plasma kallikrein currently in development
for the prevention and treatment of angioedema attacks in patients
diagnosed with HAE. BCX7353 has been generally safe and well
tolerated in the Phase 2 APeX-1 clinical trial. BioCryst is
currently conducting the Phase 3 APeX-2 clinical trial and the
long-term safety APeX-S clinical trial, both evaluating two dosage
strengths of BCX7353 administered orally once-daily as a preventive
treatment to reduce the frequency of attacks in patients with HAE.
BioCryst is also conducting the ZENITH-1 clinical trial. ZENITH-1
is a proof-of-concept Phase 2 clinical trial testing an oral liquid
formulation of BCX7353 for the treatment of acute angioedema
attacks.
About BioCryst Pharmaceuticals
BioCryst Pharmaceuticals designs, optimizes and develops novel
small-molecule medicines that address both common and rare
conditions. BioCryst has several ongoing development programs
including BCX7353, an oral treatment for hereditary angioedema,
galidesivir, a potential treatment for filoviruses, and a
preclinical program to develop oral Alk-2 inhibitors for the
treatment of fibrodysplasia ossificans progressive (FOP). 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 commitments 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: that
developing any HAE drug candidate may take longer or may be more
expensive than planned; that ongoing and future preclinical and
clinical development of HAE second generation drug candidates
(including ZENITH-1, APeX-2 and APeX-S) 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, EMA or other
applicable regulatory agency 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. 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: Thomas Staab,
BioCryst Pharmaceuticals, +1-919-859-7910
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