Biota Commences Dosing in Phase 2 Trial of Antiviral Therapy BTA074 for Topical Treatment of Condyloma
February 08 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, announced today that the first patient has been dosed in a
Phase 2 double-blind, randomized, placebo-controlled trial to
evaluate the safety, tolerability and efficacy of BTA074 5% gel in
male and female patients with condyloma, or anogenital warts,
caused by human papillomavirus (HPV) types 6 & 11.
“We are excited to progress BTA074 into a well-powered
proof-of-concept study. The currently approved topical treatments
for condyloma lack consistent efficacy and cause a considerable
amount of undesirable local skin reactions, such as erosions and
edema, often leading to the need to stop treatment. With this
larger Phase 2 study, we hope to further validate the clinical
activity of BTA074 seen in its earlier Phase 2 trial, which showed
evidence of overall clearance and a benign side effect profile,”
remarked Joseph M. Patti, PhD, president and chief executive
officer at Biota. “We now have three direct-acting antiviral
programs in the clinic, each of which has the potential to help
patients by attacking the root cause of their viral
infections.”
BTA074 is a potent and selective inhibitor of the interaction
between two viral proteins from HPV6 and HPV11, and is designed to
prevent HPV DNA replication. The Phase 2 trial is expected to
enroll approximately 210 patients with anogenital warts and will
have a 2-to-1 randomization of BTA074 5% gel to placebo gel. The
patients will be dosed twice daily for up to 16 weeks. The primary
efficacy objective is to determine the complete clearance rate for
baseline anogenital warts from the commencement of therapy to the
end of the treatment period. Secondary efficacy endpoints include
various assessments of clearance and wart area reduction for both
baseline warts and post-baseline emergent warts.
About Condyloma (Anogenital
Warts)
Condyloma infections from human papillomavirus (HPV) represent
the most frequent viral sexually transmitted disease in adults
worldwide. In the United States, approximately one to two percent
of sexually active adults between the ages of 15 to 49 develop
condyloma as the primary clinical manifestation of HPV infection.
Currently available treatments for anogenital warts typically are
divided into two categories, ablative/destructive therapies and
topical therapies. Existing topical therapies are associated with
significant mucosal toxicities manifesting as erosions and
ulcerations, which can result in therapy discontinuation. Ablative
options can be painful and scarring, and can lead to sexual
dysfunction. Another significant limitation with current therapies
is a high incidence of recurrence after successful primary
treatment.
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 potential efficacy of the
Company’s three programs in the clinic. 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 BTA074 or 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) 221-3352
m.colonnese@biotapharma.com
Beth DelGiacco
Stern Investor Relations, Inc.
(212) 362-1200
beth@sternir.com
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