Aviragen Therapeutics Announces Top-Line Results from Phase 2b SPIRITUS Trial of Vapendavir
February 13 2017 - 4:01PM
Aviragen Therapeutics (NASDAQ:AVIR), a company focused on the
discovery and development of the next generation of direct-acting
antivirals to treat infections that have limited therapeutic
options, today announced top-line data from its Phase 2b SPIRITUS
trial, a multi-center, randomized, double-blind,
placebo-controlled, dose-ranging study of vapendavir in moderate to
severe asthmatics with a rhinovirus (RV) infection. Vapendavir did
not demonstrate a statistically significant reduction in the asthma
control questionnaire-6 (ACQ-6) at day 14, the primary endpoint,
for either the 264 mg or 528 mg cohorts compared to placebo.
“We are disappointed that the SPIRITUS trial did not meet its
primary endpoint in this patient population. There was evidence of
an antiviral effect in patients that received vapendavir within the
first day following the onset of their symptoms, and as such, we
plan to take time to fully analyze the data before making a
decision on whether to initiate a study in hematopoietic stem cell
transplant patients, where the ability to stop the progression of
the RV infection could be beneficial,” stated Joseph Patti, PhD,
President and Chief Executive Officer of Aviragen. “We are
sincerely grateful for the patients, investigators and staff that
participated in the trial.”
The Phase 2b SPIRITUS clinical trial of vapendavir was conducted
at approximately 68 sites in North America and Europe.
Patients aged 18-70 years that had an established history of
moderate-to-severe asthma and a history of losing asthma control as
a result of an upper respiratory tract infection were eligible for
enrollment. The intent-to-treat (ITT) patient population consisted
of 455 randomized patients and from this group there were 168
laboratory-confirmed HRV-infected patients (ITT-infected;
ITT-I).
- Primary Endpoint Data: Subjects that received
264 mg (n=54) or 528 mg (n=57) vapendavir had a least square means
change in ACQ-6 at day 14 of -0.75 and -0.79, respectively,
compared to placebo of -0.94 (n=57). A 0.5 point change in ACQ-6 is
considered clinically relevant. The improvement of ACQ-6 in the
placebo cohort was larger than expected for this patient
population.
- Secondary Endpoint Data: The results of the
SPIRITUS study demonstrated statistically significant antiviral
effects for patients that received vapendavir within 24 hours of
first symptoms, consistent with previous studies. Secondary
endpoints evaluating the lung function measure FEV1 and reduction
in asthma exacerbations did not show significant differences
between the treatment groups and placebo.
- Safety Data: Vapendavir was shown to be
generally well tolerated and the safety profile was consistent with
previous clinical studies.
About Aviragen Therapeutics
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 four Phase 2 clinical programs: vapendavir, an oral
treatment for rhinovirus (RV) upper respiratory infections in
moderate-to-severe asthmatics; vapendavir for the treatment of RV
infections in hematopoietic stem cell transplant patients; BTA585,
an oral fusion protein inhibitor in development for the treatment
of respiratory syncytial virus infections; and BTA074, a topical
antiviral treatment for condyloma caused by human papillomavirus
types 6 & 11. For additional information about the Company,
please visit www.aviragentherapeutics.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 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 our plan to provide more clarity on whether
a clinical trial will be initiated in hematopoietic stem cell
transplant patients. 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
efficacy, 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 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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