Otonomy Announces Successful End-of-Phase 2 Meeting With the FDA for OTO-104 in Meniere's Disease
September 21 2015 - 8:46PM
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 that it has successfully completed an End-of-Phase
2 meeting with the U.S. Food and Drug Administration (FDA) for
OTO-104 in the treatment of Ménière's disease. As a result, the
company reiterates its prior guidance given in the second quarter
earnings release that it expects to initiate two parallel Phase 3
trials for OTO-104 in Ménière's patients, with the first trial
expected to begin by the end of 2015 and the second trial expected
to begin during the first quarter of 2016.
"We are pleased with the outcome of our meeting with the FDA and
have reached agreement around endpoints as well as other important
aspects for the design of our two Phase 3 trials," said David A.
Weber, Ph.D., president and CEO of Otonomy. "We look forward to
sharing details of these trials as well as providing a
comprehensive update of our entire product pipeline at our upcoming
investor and analyst day in New York on October 7, 2015."
About OTO-104
OTO-104, which has been granted Fast Track designation by the
U.S. Food and Drug Administration (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 recently completed a randomized, prospective,
double-blind, placebo-controlled single-dose Phase 2b trial in a
total of 154 Ménière's disease patients. Top-line 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 Ménière's Disease
Ménière's disease is a chronic condition characterized by acute
vertigo attacks, tinnitus, fluctuating hearing loss and a feeling
of aural fullness. Of these symptoms, the vertigo attacks are
typically most troubling for patients since they disrupt daily
activities and are difficult to anticipate and manage. In general,
patients are diagnosed with unilateral Ménière's disease in middle
age and symptoms often continue for decades. Over time, the
fluctuating hearing loss becomes permanent in many patients, and a
subset of patients will develop symptoms in their second ear.
According to the National Institute of Deafness and Other
Communication Disorders, there are more than 600,000 patients
diagnosed with Ménière's disease in the United States. There is no
known cure for Ménière's disease and there are currently no
FDA-approved drug treatments.
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. 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.
The factors referred to above that could cause the Company's
results to differ materially from those expressed or implied by
such forward-looking statements also include the risks,
uncertainties and assumptions discussed from time to time in the
Company's public filings and public announcements, including the
Company's Quarterly Report on Form 10-Q filed with the Securities
and Exchange Commission ("SEC") on August 12, 2015, and Otonomy's
future reports to be filed with the SEC.
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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