Biota Initiates Additional Clinical Trials of Laninamivir Octanoate
November 19 2013 - 6:00AM
Biota Pharmaceuticals Inc. ("Biota") (Nasdaq:BOTA) announced today
that it has commenced dosing in two Phase 1 clinical trials of
laninamivir octanoate ("LANI"), its long-acting neuraminidase
inhibitor being developed for the treatment of influenza.
One of the Phase 1 clinical trials is a single center,
randomized, double-blind, placebo-controlled, single ascending dose
study in which the safety and pharmacokinetics of LANI,
administered by inhalation via the TwinCaps® dry powder inhaler
(DPI), will be assessed in adults with mild to moderate chronic
asthma. The study is designed to enroll up to 32 subjects. The
second Phase 1 clinical trial is a thorough QT/QTc (TQT) study
designed to evaluate the effect of therapeutic and
supra-therapeutic doses of LANI on cardiac ventricular
repolarization, specifically the QT-interval, in healthy
volunteers. The study is a single center, parallel design, placebo-
and positive-controlled, double-blind, randomized trial. This trial
is designed to enroll 168 subjects. Both studies are being
conducted to support the requirements of a New Drug Application for
LANI. The Company expects top-line results from both of these
clinical studies in the first half of 2014.
"We are pleased to augment our ongoing Phase 2 IGLOO clinical
trial of LANI with these important studies and anticipate
initiating another Phase 1/2 clinical study next month in children
aged 5-17 infected with influenza," stated Russell Plumb, President
and Chief Executive Officer of Biota.
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 infectious diseases.
The Company currently has two Phase 2 clinical-stage product
candidates: LANI, which the Company is developing for the treatment
of influenza A and B infections under an IND in the U.S. through a
contract with the U.S. Office of Biomedical Advanced Research and
Development Authority (BARDA) that is designed to provide up to
$231 million in financial support to complete its clinical
development; and vapendavir, a potent, oral broad spectrum capsid
inhibitor of enteroviruses, including human rhinovirus (HRV). In
addition to these clinical-stage programs, the Company has
preclinical programs focused on developing treatments for
respiratory syncytial virus (RSV) and gram-negative, multi-drug
resistant bacterial 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. All
statements, other than historical facts, including statements
regarding the anticipated time in which the Company expects to have
top-line data from the ongoing Phase 1 trials and to initiate a
Phase 1/2 trial in children, are forward looking statements.
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,
BARDA, 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 LANI at any time for a lack of safety, tolerability,
anti-viral activity, commercial viability, regulatory or
manufacturing issues, or any other reason whatsoever; BARDA not
terminating or significantly amending the Company's existing
contract to develop LANI; a prolonged shutdown of the U.S.
government or other actions by the U.S. government that could delay
or suspend the development of LANI; the Company's ability to comply
with extensive government regulations in various countries and
regions in which it expects to conduct its clinical trials; the
Company's ability to secure, manage and retain qualified
third-party clinical research, preclinical research, data
management and contract manufacturing organizations which it relies
on to assist in the design, development and implementation of the
clinical development of LANI; the Company's ability to recruit and
manage multi-national clinical trials; the severity and seasonality
of influenza in regions where the Company is conducting its
clinical trials of LANI; 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 in the Company's Quarterly Report on Form 10-Q for the
quarters ended September 30, 2013, as filed with the SEC on
November 12, 2013.
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 Holdings Limited and
TwinCaps® is a registered trademark of Hovione FarmaCiencia SA.
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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