BioCryst Announces Initiation of ZENITH-1, a Clinical Trial to Evaluate BCX7353 as an Acute Treatment of Hereditary Angioedem...
August 02 2017 - 6:00AM
BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) announced today the
dosing of the first subject into ZENITH-1, a clinical trial
studying up to three dosage strengths of a liquid formulation of
BCX7353 given as a single oral dose for the acute treatment of
angioedema attacks in patients with hereditary angioedema (HAE).
"We are excited to launch the ZENITH-1
exploratory Phase 2 trial. Based upon pharmacokinetic and
pharmacodynamic properties of BCX7353, we believe it could be an
efficacious and convenient oral alternative to parenteral
treatments of acute angioedema attacks in patients with HAE. A
liquid formulation of BCX7353 would be a strong complement to our
prophylactic treatment program," said Jon Stonehouse, Chief
Executive Officer. "We believe this new formulation can fill an
unmet need for patients who are looking for better and easier ways
to manage their illness.”
ZENITH-1 is a randomized, double-blind,
placebo-controlled, adaptive dose-ranging trial of the efficacy,
safety and tolerability of BCX7353 for treatment of acute
angioedema attacks, and will enroll up to 60 subjects with HAE.
Blinded study drug will be dosed as an oral liquid after onset of
symptoms, for up to 3 attacks in each subject, with each subject
receiving both BCX7353 (for 2 attacks) and placebo (for one attack)
in a randomized sequence. The trial is structured with up to 3
consecutive cohorts testing single doses of 750 mg (from 12 to 36
subjects), 500 mg (up to 12 subjects) and 250 mg (up to 12
subjects), starting with 750 mg. Efficacy assessments include
patient-reported composite visual analogue scale (VAS) scores,
patient global assessment, change in symptoms, and use of rescue
medication.
Treatment effect will be assessed on
accumulating results, beginning after 12 subjects have completed
study in the first cohort (750 mg), by comparing the proportion of
BCX7353-treated and placebo-treated attacks which have a stable or
improved composite VAS at 4 hours post dose. Once a treatment
effect is demonstrated, enrollment at the 500 mg dose level will
commence. If treatment effect at the 500 mg dose level is similar
to 750 mg dose level, the 250 mg dose cohort will be enrolled.
Additional clinical trial details will be
available on www.clinicaltrials.gov.
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, an 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: 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 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 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: Thomas Staab, BioCryst Pharmaceuticals, +1-919-859-7910
BioCryst Pharmaceuticals (NASDAQ:BCRX)
Historical Stock Chart
From Mar 2024 to Apr 2024
BioCryst Pharmaceuticals (NASDAQ:BCRX)
Historical Stock Chart
From Apr 2023 to Apr 2024