Aviragen Therapeutics Resumes Enrollment in Phase 2a RSV Challenge Trial
July 12 2016 - 7:00AM
Aviragen Therapeutics, Inc. (NASDAQ:AVIR) (formerly Biota
Pharmaceuticals, Inc.), a pharmaceutical company that is developing
the next generation of antivirals, today announced it is resuming
enrollment in its Phase 2a challenge study of BTA585, an oral
fusion inhibitor in development for the treatment and prevention of
respiratory syncytial virus (RSV) infections.
“We are pleased to have received approval from the MHRA to
continue the Phase 2a challenge study of BTA585. The decision was
based on our submission of all requested information and
documentation and the subsequent review by the UK regulatory
authority. We continue to anticipate completing the trial by the
end of 2016,” said Joseph M. Patti, Ph.D., President and Chief
Executive Officer of Aviragen Therapeutics.
In addition to receiving MHRA and Ethics Committee approval to
resume enrollment and dosing in the Phase 2a trial, the Company
also reported that it has received written confirmation from the
U.S. Food and Drug Administration (FDA) of the previously announced
clinical hold of the investigational new drug (IND) application for
BTA585. The Company plans to submit a complete response to
the FDA by the first quarter of 2017, including requested data from
additional rodent studies.
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. 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.
About Aviragen Therapeutics, Inc.Aviragen
Therapeutics is focused on the discovery and development of the
next generation 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: vapendavir, an oral
treatment for human rhinovirus upper (HRV) respiratory infections
in moderate-to-severe asthmatics currently being evaluated in the
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.aviragentherapeutics.com.
Forward Looking StatementsThis 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 Aviragen
Therapeutics' business, operations and financial performance. Any
statements that are not of historical facts may be deemed to be
forward-looking statements. 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 timing of completing the Phase 2a RSV
challenge study, the timing of submitting a complete response to
the clinical hold to the FDA, the Company, the 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.
Contacts:
Mark Colonnese
Executive Vice President and Chief Financial Officer
Aviragen Therapeutics, Inc.
(678) 221-3381
mcolonnese@aviragentherapeutics.com
Beth DelGiacco
Stern Investor Relations, Inc.
(212) 362-1200
beth@sternir.com
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