Otonomy to Present Results for AuriPro(TM) Phase 3 and OTO-104 Phase 2b Clinical Trials at 2015 AAO-HNSF Annual Meeting
September 24 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 upcoming presentation of results from two of
its programs; Phase 3 trials evaluating AuriProTM in pediatric
patients with middle ear effusion undergoing tympanostomy tube
placement surgery, and a Phase 2b trial evaluating OTO-104 in
patients with unilateral Ménière's disease. Clinical results from
these studies will be presented at the 2015 American Academy of
Otolaryngology - Head & Neck Surgery Foundation (AAO-HNSF)
Annual Meeting being held in Dallas on September 27-30, 2015. The
results for both programs have been previously announced or
presented.
Paul R. Lambert, M.D., Professor and Chair, Department of
Otolaryngology, Medical University of South Carolina, will present
the OTO-104 data on Monday, September 28, in a presentation titled,
"Phase 2b Efficacy and Safety of Intratympanic OTO-104 in Ménière's
Disease." The presentation will take place in the East Fork Room in
the Kay Bailey Hutchison Convention Center at 8:18 a.m. CDT.
Albert H. Park, M.D., Division Chief Pediatric Otolaryngology,
Professor in Department of Surgery and Pediatrics, University of
Utah, will present the AuriPro (OTO-201) data on Monday, September
28, in a presentation titled, "Efficacy from Combined Analysis of
Two Phase 3 Trials of Ciprofloxacin Thermosensitive Gel in
Pediatric Subjects Getting Ear Tubes." The presentation will take
place in the Trinity Ballroom 1 in the Omni Dallas Hotel at 3:30
p.m. CDT.
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.
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 AuriPro 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 AuriPro in the United States in the first quarter of
2016. AuriPro 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 OTO-104
OTO-104, which has been granted Fast Track designation by FDA,
is a sustained-exposure formulation of the steroid dexamethasone in
development for the treatment of Ménière's disease and other inner
ear conditions. Otonomy has completed a randomized,
prospective, double-blind, placebo-controlled single-dose Phase 2b
trial in a total of 154 Ménière's disease patients. Results
indicate that OTO-104 narrowly missed the primary efficacy endpoint
(p=0.067) but achieved statistical significance (p<0.05) for
multiple prospectively defined secondary vertigo endpoints at
multiple time points. Based on these
results Otonomy intends to initiate two parallel Phase 3
trials, with one of the trials expected to begin by the end of 2015
and the second trial expected to begin during the first quarter of
2016. OTO-104 is also being evaluated in a multiple-dose safety
study in the United Kingdom in patients with Ménière's
disease, and enrollment has been completed with a total of 128
patients.
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. 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 the FDA has assigned a PDUFA action date of December 25, 2015
for the company'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. 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 initiation, timing and design of Otonomy's
Phase 3 clinical trials with OTO-104 and the timing of the launch
of AuriPro™. 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.
Otonomy undertakes no obligation to update any forward-looking
statements, whether as a result of new information, future events
or otherwise, except as required by applicable 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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