Otonomy Completes Enrollment in Phase 2 Clinical Trial for AuriPro(TM) in Pediatric Patients With Acute Otitis Media With Tym...
May 07 2015 - 7:00AM
Otonomy, Inc. (Nasdaq:OTIC), a clinical-stage biopharmaceutical
company focused on the development and commercialization of
innovative therapeutics for diseases and disorders of the inner and
middle ear, today announced it has completed enrollment in a Phase
2 clinical trial evaluating AuriPro™, a sustained-exposure
formulation of the antibiotic ciprofloxacin, for the treatment of
pediatric patients with acute otitis media with tympanostomy tubes
(AOMT).
"We are very encouraged by the initial results of this trial
which support the feasibility of administering AuriPro to fully
alert children in a physician's office setting," said David A.
Weber, Ph.D., president and CEO of Otonomy. "The rapid enrollment
also demonstrates physician and caregiver interest in a product
that can potentially provide a full course of antibiotic treatment
in one ENT-administered dose."
The one-month, prospective, multicenter, open-label Phase 2
clinical trial enrolled a total of 39 pediatric patients in the
United States. The trial is designed to characterize safety,
procedural factors and clinical effect of AuriPro administered in
subjects with AOMT.
About AuriPro
AuriPro is a sustained-exposure formulation of the antibiotic
ciprofloxacin in development for the treatment of middle ear
effusion in pediatric patients undergoing tympanostomy tube
placement (TTP) surgery. AuriPro has been formulated to provide
sustained-exposure of ciprofloxacin so that a single administration
provides a full course of treatment. There are approximately one
million TTP surgeries performed each year in the United States, and
antibiotic ear drops are used in nearly all cases. Despite their
routine use, no antibiotic ear drop has received FDA approval for
this indication. Moreover, current ear drop products require
multi-dose, multi-day regimens for efficacy. Full compliance with
these regimens can be challenging, and missed antibiotic doses can
compromise efficacy and increase the potential for bacterial
resistance.
Otonomy filed a New Drug Application (NDA) for AuriPro for the
treatment of middle ear effusion in pediatric patients undergoing
TTP surgery to the FDA as of February 25, 2015. If approved within
the standard review period, Otonomy anticipates a commercial launch
for AuriPro in the United States in the first quarter of 2016.
About Otonomy
Otonomy is a clinical-stage biopharmaceutical company focused on
the development and commercialization of innovative therapeutics
for diseases and disorders of the ear. Otonomy's proprietary
technology provides sustained exposure of drugs to the middle and
inner ear following a single intratympanic injection. Otonomy has
three product candidates in development. AuriPro™ is an antibiotic
that has completed Phase 3 clinical trials in pediatric patients
with middle ear effusion at the time of tympanostomy tube placement
surgery, and a New Drug Application for AuriPro in this indication
has been filed with the FDA. OTO-104 is a steroid that is in the
first of two pivotal clinical studies for the treatment of patients
with Ménière's disease. OTO-311 is an NMDA receptor antagonist in
development as a treatment for tinnitus. For additional information
please visit www.otonomy.com.
Cautionary Note Regarding Forward Looking
Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995. Forward-looking statements generally relate to future events
or Otonomy's future financial or operating performance.
Forward-looking statements in this press release include, but are
not limited to, Otonomy's expectations regarding the commercial
launch of AuriPro in the United States and the Phase 2 clinical
trial evaluating AuriPro for the treatment of pediatric patients
with acute otitis media with tympanostomy tubes (AOMT). Otonomy's
expectations regarding these matters may not materialize, and
actual results in future periods are subject to risks and
uncertainties. Actual results may differ materially from those
indicated by these forward-looking statements as a result of these
risks and uncertainties, including but not limited to: the
uncertainties inherent in the clinical drug development process,
including, without limitation, Otonomy's ability to adequately
demonstrate the safety and efficacy of its product candidates, the
preclinical and clinical results for its product candidates, which
may not support further development of product candidates, and
challenges related to patient enrollment in clinical trials;
Otonomy's ability to obtain regulatory approval for its product
candidates; side effects or adverse events associated with
Otonomy's product candidates; developments related to competitors
and the industry; Otonomy's dependence on third parties to conduct
preclinical studies and clinical trials; Otonomy's dependence on
third parties for the manufacture of products; Otonomy's dependence
on a small number of suppliers for raw materials; Otonomy's ability
to protect its intellectual property related to product candidates
in the United States and throughout the world; and other risks.
Information regarding the foregoing and additional risks may be
found in the section entitled "Risk Factors" in Otonomy's Annual
Report on Form 10-K filed with the Securities and Exchange
Commission (the SEC) on March 18, 2015, and Otonomy's future
reports to be filed with the SEC. The forward-looking statements in
this press release are based on information available to Otonomy as
of the date hereof. Otonomy disclaims any obligation to update any
forward-looking statements, except as required by law.
CONTACT: Media Inquiries
Canale Communications
Heidi Chokeir, Ph.D.
Vice President
619.849.5377
heidi@canalecomm.com
Investor Inquiries
Westwicke Partners
Robert H. Uhl
Managing Director
858.356.5932
robert.uhl@westwicke.com
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