Biota Announces Positive Results From Phase 1 Program for Direct Acting RSV Antiviral BTA585
March 09 2016 - 7:46PM
Biota Pharmaceuticals, Inc. (NASDAQ:BOTA), a biopharmaceutical
company focused on the discovery and development of direct-acting
antivirals that address infections that have limited therapeutic
options, announced today top-line safety and pharmacokinetic (PK)
data from the Phase 1 multiple ascending dose (MAD) trial of
BTA585, an oral respiratory syncytial virus (RSV) fusion inhibitor
in development for the treatment and prevention of RSV infections.
Results from the MAD trial indicated BTA585 was generally well
tolerated at all dose levels; there were no serious adverse events,
and no drug-related clinically-significant adverse changes in ECGs
or clinical laboratory values were observed.
“We dosed a total of 66 subjects in the Phase 1
SAD and MAD studies and the data to date indicates that oral
administration of the fusion inhibitor was well tolerated at all
doses tested and that antiviral levels of BTA585 were rapidly
achieved and maintained in the plasma and nasal wash fluid,” stated
Joseph Patti, PhD, president and chief executive officer of Biota.
“With these favorable safety and PK data in hand, along with the
recent Fast Track designation by the FDA, we are looking forward to
starting a Phase 2a RSV challenge efficacy study next quarter and
anticipate top-line results in the second half of 2016.”
The blinded, placebo-controlled MAD study, which
was conducted in the U.S. under an Investigational New Drug (IND)
Application, evaluated the safety and PK of three cohorts of
healthy volunteers (100, 400, and 600 mg BTA585) dosed orally twice
a day for seven consecutive days. Each of the dose cohorts
consisted of eight subjects that received BTA585 and four that
received placebo. Adverse events occurring in more than two
BTA585-treated subjects were headache and chromaturia. Additional
results showed that BTA585 plasma Cmax was rapidly achieved at
approximately one hour following oral dosing, exposure was
dose-proportional, there was no accumulation of BTA585 over the
duration of dosing and the half-life (T1/2) was approximately five
to six hours.
About Respiratory Syncytial Virus (RSV)
RSV is a major cause of acute upper (colds) and
lower (pneumonia and bronchiolitis) respiratory tract infections in
infants, young children, and adults. Each year in the United
States, RSV accounts for an estimated 2.1 million medical visits in
children under the age of five, with many of the children afflicted
requiring hospitalization. At the present time there is no
effective vaccine to prevent or recommended therapy to treat RSV
infections.
About Biota Pharmaceuticals, Inc.
Biota Pharmaceuticals is focused on the
discovery and development of direct-acting antivirals to treat
infections that have limited therapeutic options and affect a
significant number of patients globally. The Company has three
product candidates in active clinical development: These include
vapendavir, an oral treatment for human rhinovirus infections in
moderate-to-severe asthmatics currently being evaluated in the
Company’s ongoing Phase 2b SPIRITUS trial; BTA585, an oral fusion
protein inhibitor in Phase 2 development for the treatment and
prevention of respiratory syncytial virus (RSV) infections and has
received Fast Track designation by the U.S. FDA; and BTA074, a
topical antiviral treatment in Phase 2 development for condyloma
caused by human papillomavirus types 6 & 11. For additional
information about the Company, please visit
www.biotapharma.com.
Forward-Looking Statements
This press release contains forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995 that involve known and unknown risks and
uncertainties concerning Biota’s business, operations and financial
performance. Any statements that are not of historical facts may be
deemed to be forward-looking statements, including the timing of
the Phase 2a RSV challenge study and of the expected timing of
top-line results from this study. Various important factors could
cause actual results, performance, events or achievements to
materially differ from those expressed or implied by
forward-looking statements, including: the Company, the U.S. Food
and Drug Administration (FDA) or a similar regulatory body in
another country, a data safety monitoring board, or an
institutional review board delaying, limiting, suspending or
terminating the clinical development of any of the Company's
product candidates at any time for a lack of safety, tolerability,
regulatory or manufacturing issues, or any other reason whatsoever;
the Company's ability to secure, manage and retain qualified
third-party clinical research data management and contract
manufacturing organizations upon which it relies to assist in the
design, development, implementation and execution of the clinical
development of all its product candidates and those organizations
ability to successfully execute their contracted responsibilities;
the Company’s ability to comply with applicable government
regulations in various countries and regions in which we are
conducting, or expect to conduct, clinical trials; and other
cautionary statements contained elsewhere in this press release and
in our Annual Report on Form 10-K, Quarterly Report on Form 10-Q
and our other reports filed with the Securities and Exchange
Commission. There may be events in the future that the Company is
unable to predict, or over which it has no control, and the
Company’s business, financial condition, results of operations and
prospects may change in the future. The Company may not update
these forward-looking statements more frequently than quarterly
unless it has an obligation under U.S. Federal securities laws to
do so.
Biota is a registered trademark of Biota Pharmaceuticals,
Inc.
Contacts:
Mark Colonnese
Executive Vice President and Chief Financial Officer
Biota Pharmaceuticals, Inc.
(678) 221-3381
m.colonnese@biotapharma.com
Beth DelGiacco
Stern Investor Relations, Inc.
(212) 362-1200
beth@sternir.com
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