Otonomy Completes Enrollment in OTIPRIO(TM) Phase 2 Trial and Demonstrates Clinical Feasibility in Patients With Acute Otitis...
December 01 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 ear,
today announced it has completed enrollment in a Phase 2 trial of
OTIPRIOTM in patients with acute otitis externa, also known as
swimmer's ear, and that preliminary results demonstrate clinical
feasibility of OTIPRIO for this label expansion indication.
The one-month, prospective, multicenter, open label Phase 2
clinical trial enrolled a total of 75 pediatric and adult patients
with unilateral acute otitis externa. Patients were randomized to
receive a single administration of OTIPRIO at one of three dose
volumes: 0.1 mL, 0.2 mL and 0.4 mL. Results of this trial
demonstrate the feasibility of administering OTIPRIO, a
thermosensitive gel containing ciprofloxacin, into the external ear
canal of awake patients by a physician in the office setting. In
addition, preliminary results demonstrate that a single
administration of OTIPRIO provided clinical cure at Day 15 in the
majority of patients with a greater than 80 percent rate of
clinical cure for patients treated with the 0.2 mL (12 mg) dose,
which is the preferred dose for further development. Final results
of the trial will be presented at an upcoming medical
conference.
"We are very encouraged by the preliminary results of this trial
which support the feasibility of treating otitis externa patients
with a single administration of OTIPRIO in the physician's office,"
said David A. Weber, Ph.D., president and CEO of Otonomy.
"Furthermore, we believe that these results support the initiation
of a registration program for OTIPRIO in this label expansion
indication and we intend to discuss the requirements for such a
program with the FDA following our upcoming PDUFA date for
OTIPRIO's lead indication."
The U.S. Food and Drug Administration (FDA) has assigned a
Prescription Drug User Fee Act (PDUFA) action date of December 25,
2015 for Otonomy's New Drug Application (NDA) for OTIPRIO as a
treatment of middle ear effusion in pediatric patients undergoing
tympanostomy tube placement surgery.
About OTIPRIOTM
OTIPRIOTM is a physician administered, single dose formulation
of ciprofloxacin in development for various indications that are
currently treated with multi-dose, multi-day antibiotic ear drops.
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 tympanostomy tube
placement (TTP) surgery. There are approximately one million TTP
surgeries performed each year in the United States, and antibiotic
ear drops are used in nearly all cases although they are not
FDA-approved for this indication. If OTIPRIO is approved on or
before its PDUFA date, Otonomy anticipates a commercial launch in
the United States in the first quarter of 2016. OTIPRIO is also in
development for two potential label expansion indications: a Phase
2 feasibility trial has been completed and a second Phase 2 trial
is being planned for the first quarter of 2016 in pediatric
patients with acute otitis media with tympanostomy tubes (AOMT),
and a Phase 2 feasibility trial in patients with acute otitis
externa (swimmer's ear) has recently been completed.
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 the company's New Drug Application. OTO-104 is a steroid in
development for the treatment of Ménière's disease and other
balance and hearing disorders. A Phase 3 trial in Ménière's disease
patients has been initiated in the United States with a second
trial expected to begin in the EU during the first quarter of 2016.
OTO-311 is an NMDA receptor antagonist for the treatment of
tinnitus that is in a Phase 1 clinical safety trial. 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 of the FDA meeting regarding OTIPRIO
for otitis externa, the timing of its second Phase 2 clinical trial
for OTIPRIO for the treatment of acute otitis media with
tympanostomy tubes (AOMT), and the timing regarding the Phase 3
clinical trials for OTO-104. 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 November 10, 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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