Otonomy Initiates Open-Label Clinical Trial for OTIPRIO(TM) in Pediatric Patients With History of Otitis Media Requiring Tymp...
November 03 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 ear,
today announced the enrollment of the first patients in an
open-label Phase 3b clinical trial evaluating OTIPRIO™ (formerly
known as AuriPro™) in pediatric patients with a history of otitis
media requiring tympanostomy tubes.
The study expands enrollment compared to the previous Phase 3
studies of OTIPRIO to include patients undergoing common concurrent
surgeries, including adenoidectomy and nasal endoscopy.
Additionally, patients without bilateral middle ear effusion on the
day of surgery will be included in the study. The observation
period will be extended to two months post-surgery, and a
questionnaire will be administered to assess caregiver burden for
those patients who require treatment with antibiotic ear drops.
"This study will provide important information regarding the
types of patients undergoing tympanostomy tube placement surgery
that could potentially benefit from treatment with OTIPRIO
administered as a single dose in each ear by the physician during
surgery," said David A. Weber, Ph.D., president and CEO of Otonomy.
"This is also the first study to evaluate caregiver burden
associated with multi-dose, multi-day antibiotic ear drops which
will be assessed in a subset of study patients who require ear drop
administration."
The two-month, prospective, multicenter, open-label Phase 3b
clinical trial is expected to enroll approximately 500 patients,
ages 6 months to 17 years old, in the United States. The clinical
effect of OTIPRIO will be measured through assessment of the
presence of otorrhea, or drainage from the tube. Safety will be
assessed through adverse event reporting and otoscopic
examinations. Patients will receive a single administration of
OTIPRIO in each ear during surgery.
About OTIPRIOTM
OTIPRIOTM 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. OTIPRIO 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.
The U.S. Food and Drug Administration (FDA) has assigned a PDUFA
action date of December 25, 2015 for the company's New Drug
Application (NDA) for OTIPRIO for the treatment of middle ear
effusion in pediatric patients undergoing TTP surgery. If approved
within the standard review period, Otonomy anticipates a commercial
launch for OTIPRIO in the United States in the first quarter of
2016. OTIPRIO is also being evaluated for two potential label
expansion indications: a Phase 2 feasibility trial has been
completed in pediatric patients with acute otitis media with
tympanostomy tubes (AOMT), and a Phase 2 feasibility trial is
ongoing for patients with otitis externa (swimmer's ear).
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 ear
following a single administration. Otonomy has three product
candidates in development. OTIPRIO™ 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 the FDA has assigned a PDUFA action date of December 25, 2015
for Otonomy's New Drug Application. OTO-104 is a steroid that has
completed a Phase 2b clinical trial in 154 patients with Ménière's
disease. Based on these results, Otonomy intends to initiate two
parallel Phase 3 trials for OTO-104 in Ménière's disease patients
with at least one trial initiated by the end of 2015. OTO-311 is an
NMDA receptor antagonist in development as a treatment for
tinnitus. A Phase 1 clinical safety trial for OTO-311 is expected
to begin before the end of 2015. 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 future financial or operating performance of Otonomy.
Forward-looking statements in this press release include, but are
not limited to, Otonomy's expectations regarding the timing of
commercial launch, the timing regarding the Phase 3 clinical trials
for OTO-104, and the timing of the initiation of the Phase 1
clinical trial for OTO-311. 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: Otonomy's limited operating history and its expectation
that it will incur significant losses for the foreseeable future;
Otonomy's ability to obtain substantial additional financing;
Otonomy's dependence on the regulatory and commercial success of
OTIPRIO and OTO-104 and advancing additional product candidates,
such as OTO-311; 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; competition in the
biopharmaceutical 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; expectations regarding potential market size,
opportunity and growth; Otonomy's ability to manage operating
expenses; implementation of Otonomy's business model and strategic
plans for its business, products and technology; and other risks.
Information regarding the foregoing and additional risks may be
found in the section entitled "Risk Factors" in Otonomy's Quarterly
Report on Form 10-Q filed with the Securities and Exchange
Commission (the "SEC") on August 12, 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.
Senior 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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