Aviragen Therapeutics Provides Update on Phase 2a Trial of BTA585 for the Treatment of RSV Infections
May 26 2016 - 4:30PM
Aviragen Therapeutics, Inc. (NASDAQ:AVIR) (formerly Biota
Pharmaceuticals, Inc.), a pharmaceutical company that is developing
the next generation of antivirals, today announced that it has
voluntarily decided to delay further enrollment in the Phase 2a
trial of BTA585 for the treatment of RSV infections being conducted
in the U.K. This decision emanated from a lab report from one
subject showing an increase of a cardiac enzyme level coupled with
transient ECG changes, which led to a hospitalization of less than
24 hours. The subject’s ECGs were normal prior to hospitalization
and the cardiac enzyme levels returned to baseline shortly
thereafter.
The Company also reported that subsequent to the submission of
the requisite safety report to the regulatory authorities, it
received verbal communication from the U.S. Food and Drug
Administration (FDA) that the investigational new drug application
(IND) for BTA585 has been placed on clinical hold for studies being
conducted in the U.S. under the IND. There are currently no trials
of BTA585 being conducted under the IND. More specific written
information from the FDA concerning the clinical hold is expected
within 30 days.
“Patient safety is paramount to us, which led to our decision to
voluntarily delay enrollment. We have proactively reached out
to the Medicines and Healthcare Products Regulatory Agency (MHRA),
the regulatory authority in the U.K., to discuss this event and any
implications it may have on the continued clinical development of
BTA585,” said Joseph M. Patti, PhD, President and Chief Executive
Officer of Aviragen Therapeutics.
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: These include
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, including the timing of receiving
written information from the U.S. Food and Drug
Administration (FDA). 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 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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