Otonomy Initiates Phase 2 Clinical Trial for AuriPro(TM) in Label Expansion Indication
March 26 2015 - 7:30AM
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 the enrollment of the first patients in
a Phase 2 clinical trial evaluating AuriProTM for the treatment of
pediatric patients with acute otitis media with tympanostomy tubes
(AOMT). A New Drug Application (NDA) has been submitted to the U.S.
Food and Drug Administration (FDA) for AuriPro, a
sustained-exposure formulation of the antibiotic ciprofloxacin, as
a treatment of middle ear effusion in pediatric patients undergoing
tympanostomy tube placement (TTP) surgery.
"Recurrent ear infections occur frequently in patients with ear
tubes, and locally administered antibiotics are considered standard
of care by the American Academy of Otolaryngology – Head and Neck
Surgery," said David A. Weber, Ph.D., president and CEO of Otonomy.
"AuriPro has potential advantages to multi-dose, multi-day ear
drops by providing a full course of treatment with a single dose
administered by the ENT in the office. We look forward to
evaluating AuriPro in this additional indication."
The one-month, prospective, multicenter, open-label Phase 2
clinical trial is expected to enroll a total of 30 patients, ages 6
months to 17 years old, in the United States. The trial is designed
to characterize safety, procedural factors and clinical effect of
AuriPro administered in subjects with AOMT. Clinical effect of
AuriPro will be measured for up to two weeks through assessment of
the presence of otorrhea, or drainage from the tube.
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 submitted a New Drug Application (NDA) for AuriPro for
the treatment of middle ear effusion in pediatric patients
undergoing TTP surgery to the FDA on 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 submitted to 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, the potential advantages of AuriPro for pediatric
patients with AOMT, Otonomy's expectations regarding enrollment for
the Phase 2 clinical trial evaluating AuriPro for the treatment of
pediatric patients with AOMT, and Otonomy's expectations regarding
the commercial launch of AuriPro in the United States. 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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