Biota Announces Positive Phase 1 Data for Direct-Acting RSV Antiviral BTA585
December 18 2015 - 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, announced today that it completed an initial Phase 1
single ascending dose (SAD) trial of BTA585, an oral respiratory
syncytial virus (RSV) fusion inhibitor in development for the
treatment and prevention of RSV infections. Top-line data
demonstrated that BTA585 was generally well tolerated at all dose
levels; there were no serious adverse events (AEs), and no
drug-related clinically-significant changes in ECGs or clinical
laboratory values were observed. The Company plans to present the
full data from this trial at an upcoming scientific meeting in
2016.
“We are encouraged by the data from this
first-in-man study and, based on these favorable results, we have
commenced dosing in a Phase 1 multiple ascending dose (MAD) study
of BTA585 in healthy volunteers. We anticipate top-line data from
the MAD trial in the first half of 2016,” stated Joseph Patti, PhD,
president and chief executive officer of Biota. “Given the
significant demand for a new modality to treat potentially
life-threatening RSV infections in the pediatric, elderly, and
immunocompromised patient populations, we are pleased with the
progress we’ve made with BTA585 and look forward to building upon
the momentum by initiating a Phase 2 trial in the first half of
2016.”
The blinded, placebo-controlled SAD study, which
was conducted in the United States under an Investigational New
Drug Application (IND), evaluated the safety and pharmacokinetics
(PK) of five oral doses of BTA585 (50, 100, 200, 400, and 500 mg)
in healthy volunteers. In addition, the 100 mg cohort included an
evaluation of the effect of food on the PK profile of BTA585. Each
of the dose cohorts consisted of seven subjects that received
BTA585 and three that received placebo. Overall, there was low
incidence of AEs with BTA585 treatment. AEs occurring in more than
two BTA585-treated subjects included headache, nausea, and
chromaturia. In the fasted subjects, pharmacokinetic data
demonstrated that doses ≥ 100 mg achieved BTA585 plasma levels that
exceeded the mean EC50 of RSV clinical isolates for 24 hours. The
EC50 represents the concentration of drug that is required for 50%
inhibition of viral replication in vitro. The BTA585 plasma Cmax
was rapidly achieved at approximately one hour following oral
dosing and the half-life (T1/2) was approximately five to six
hours. Additionally, dosing of BTA585 with a high fat meal did not
adversely affect the PK.
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 1 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
top-line data from the Phase 1 multiple ascending dose study for
BTA585; plans to present the full data from the SAD trial at an
upcoming scientific meeting in 2016; the timing of initiating a
Phase 2 trial for BTA585; and other cautionary statements contained
elsewhere in this press release and in the Company’s Annual Report
on Form 10-K for the year ended June 30, 2015, as filed with the
U.S. Securities and Exchange Commission, on September 11, 2015.
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
Sarah McCabe
Stern Investor Relations, Inc.
(212) 362-1200
sarah@sternir.com
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