Biota Initiates Phase 2a Efficacy Study of BTA585 for the Treatment of RSV Infections
April 11 2016 - 7:00AM
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, today announced the initiation of its Phase 2a challenge
study of BTA585, an oral fusion inhibitor in development for the
treatment and prevention of respiratory syncytial virus (RSV)
infections. BTA585 has received Fast Track designation from the
U.S. Food and Drug Administration (FDA) for RSV infections in
infants, young children and adults.
“We are pleased to initiate this Phase 2a
challenge study just seven months after initiating our first-in-man
Phase 1 study with BTA585. The rapid progress of the program has
been encouraging and reinforces our commitment to developing a safe
and efficacious treatment for the millions of children that suffer
annually from serious RSV infections,” commented Joseph Patti, PhD,
president and chief executive officer of Biota. “We expect data
readout from this challenge study later this year, which will help
inform our plans for a Phase 2b natural exposure trial in this
important indication.”
The double-blind, placebo-controlled, Phase 2a trial is designed
to evaluate the safety, pharmacokinetics, and antiviral activity of
orally dosed BTA585 in healthy volunteers challenged intranasally
with RSV. Following a positive test for RSV or five days after
challenge, approximately 60 healthy adults will be randomized to
receive either BTA585 or placebo, dosed twice daily for seven days
and monitored for 28 days. The primary endpoint of the study is
area under the curve for the viral load in nasal wash among
subjects who test positive for RSV prior to dosing. Secondary
efficacy endpoints include measures of RSV clinical symptoms and
other viral load endpoints such as peak viral load and time to
cessation of virus detection. The study includes assessment of PK
levels in both plasma and nasal wash.
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 that has received Fast Track designation by the
U.S. FDA, in Phase 2 development for the treatment and prevention
of respiratory syncytial virus (RSV) infections; 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 data 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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