Biota Reports Top-Line Data From Its Phase 2 "IGLOO" Trial of Laninamivir Octanoate
August 01 2014 - 7:00AM
Biota Pharmaceuticals, Inc. (Nasdaq:BOTA) (the "Company") today
announced top-line data from a randomized, double-blind,
placebo-controlled, parallel-arm Phase 2 clinical trial comparing
the safety and efficacy of a 40 mg and 80 mg dose of laninamivir
octanoate ("LANI") to placebo. The trial, referred to as IGLOO,
enrolled 639 patients across 12 countries in the Northern and
Southern Hemisphere from June 2013 to April 2014. Of the 639
patients enrolled, 248, or 39%, had PCR confirmed influenza A or B
virus and were included in the intent-to-treat efficacy analyses.
Approximately 75% and 19% of the influenza-confirmed patients were
infected with influenza A H1N1 2009 and H3N2, respectively, with 6%
being infected with influenza B.
As compared to placebo, neither the 40 mg or 80 mg cohort
achieved a statistically significant reduction in the median time
to alleviation of influenza symptoms as measured by the Flu-iiQ
patient-recorded outcome questionnaire (p=0.248 and p=0.776,
respectively), which was the primary endpoint of the study. The
median time to alleviation of influenza symptoms was 102.3 hours
for the 40 mg cohort and 103.2 hours for the 80 mg cohort, as
compared to 104.1 hours for the placebo cohort.
Patients in both the 40 mg (p<0.001) and 80 mg (p=0.070)
cohorts demonstrated a statistically significant reduction in viral
shedding on Day 3 of the study compared to placebo as quantified by
qRT-PCR. In addition, a statistically significant proportion of
patients in both the 40 mg (p=0.002) and 80 mg (p=0.020) cohorts
were culture negative on Day 3 of the study as compared to placebo.
Influenza-infected patients in the 40 mg cohort also demonstrated a
statistically significant reduction in the incidence of secondary
bacterial infections as compared to placebo (p=0.013). The nature
and extent of adverse events were similar in the three cohorts,
with diarrhea (3.1% vs. 0.9%), headache (1.4% vs. 0.5%), gastritis
(1.4% vs. 0%), urinary tract infection (1.4% vs. 0%), and sinusitis
(1.2% vs. 0.9%) being the most common adverse events that occurred
more frequently in the treatment cohorts as compared to placebo.
The incidence of serious adverse events was low and balanced across
the three cohorts.
"It is disappointing that the rapid and significant onset of
antiviral activity against the influenza virus that the two
treatment arms demonstrated with LANI did not translate into a
meaningful reduction in the time to alleviate patient-reported
influenza symptoms," stated Russell H. Plumb, the Company's
President and CEO. "We expect to complete a full analysis of
additional clinical, safety, and pharmacokinetic data forthcoming
from this trial over the next several months; however, at this time
we do not have any plans to independently advance the development
of LANI for the treatment of influenza and intend to evaluate next
steps for the LANI program outside of Japan with our partner,
Daiichi Sankyo."
The Company plans to provide a detailed update on the full
efficacy and safety results of the Phase 2 IGLOO trial, the status
of the LANI program and its corporate strategy during its fourth
quarter and fiscal year-end earnings call in early September.
About Laninamivir Octanoate (LANI)
Laninamivir octanoate is a second-generation octanoyl ester
prodrug of laninamivir that has demonstrated in vitro
neuraminidase-inhibitory activity against influenza A and B
viruses, including subtypes N1 to N9, swine origin H1N1 strains and
oseltamivir-resistant viruses. Laninamivir octanoate has
long-lasting antiviral activity and exhibits a calculated half-life
of approximately 58 hours in the respiratory tract. In a previous
Phase 3 clinical trial, a single 40 mg inhaled dose of laninamivir
octanoate exhibited efficacy similar to that of daily repeated
doses of oseltamivir phosphate.
In 2003, the Company and Daiichi Sankyo cross-licensed
intellectual property related to long-acting neuraminidase
inhibitors, of which the lead product, laninamivir octanoate, has
been successfully developed and subsequently marketed in Japan by
Daiichi Sankyo as Inavir® for the treatment and prevention of
influenza A and B infections. The Company has been developing
laninamivir octanoate outside of Japan for the treatment of
influenza A and B infections.
About Biota
Biota Pharmaceuticals, Inc. is a biopharmaceutical company
focused on the discovery and development of products to prevent and
treat serious and potentially life-threatening viral respiratory
infectious diseases. The Company currently has two Phase 2
clinical-stage product candidates: laninamivir octanoate, which the
Company is developing for the treatment of influenza A and B
infections; and vapendavir, a potent, oral broad spectrum capsid
inhibitor of enteroviruses, including human rhinovirus and EV-71,
which is being developed to treat patients with underlying
respiratory illnesses, such as asthma and chronic obstructive
pulmonary disease (COPD). In addition to these clinical development
programs, the Company also has late-stage preclinical programs
focused on developing oral antivirals for the treatment of
respiratory syncytial virus infections. For additional information
about the Company, please visit www.biotapharma.com.
Safe Harbor Statement
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. Any
statements that are not historical facts may be deemed to be
forward-looking statements, including statements related
to the timing of additional clinical, safety and
pharmacokinetic data from the IGLOO Phase 2 trial, the Company's
current plan to not independently advance the development of LANI
for the treatment of influenza, the Company's intent to evaluate
next steps for the LANI program outside of Japan with its partner,
Daiichi Sankyo, and the Company's plan to provide a more detailed
update on the full results of the Phase 2 IGLOO trial, the status
of the LANI program and its corporate strategy during its fourth
quarter and fiscal year-end earnings call in early September.
Various important factors could cause actual results, performance,
events or achievements to materially differ from those expressed or
implied by the forward-looking statements, including: the Company's
ability to receive and analyze additional data from the IGLOO trial
on a timely basis; future changes in the Company's strategy and the
implementation of those changes; 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, 2013, as
filed with the U.S. Securities and Exchange Commission, or SEC, on
September 27, 2013 and its Form 10-Q's as filed with the SEC on
November 12, 2013, February 10, 2014 and May 12, 2014.
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.
Inavir® is a registered trademark of Daiichi Sankyo Company,
Ltd.
CONTACT: Russell H. Plumb
Chief Executive Officer
(678) 221-3351
r.plumb@biotapharma.com
Lee M. Stern
The Trout Group
(646) 378-2922
lstern@troutgroup.com
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