Otonomy Initiates Patient Enrollment in U.S. Phase 3 Clinical Trial of OTO-104 in Meniere's Disease
November 18 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 the enrollment of the first patients in the U.S.
Phase 3 clinical trial of OTO-104 in Ménière's disease. A second
Phase 3 trial is expected to be initiated in the EU in the first
quarter of 2016.
"Initiation of Phase 3 for OTO-104 in Ménière's disease marks an
important milestone for this program and for our company whose
founder suffers from this debilitating vertigo disorder," said
David A. Weber, Ph.D., president and CEO of Otonomy. "We look
forward to leveraging the valuable lessons we learned from our
Phase 2b trial and reviewed during our End-of-Phase 2 meeting with
the FDA, to successfully implement this Phase 3 program with a goal
of providing results in the second half of 2017."
The 16-week, prospective, randomized, double-blind,
placebo-controlled Phase 3 trial will enroll approximately 160
patients with unilateral Ménière's disease at multiple clinical
sites in the United States. The primary endpoint of the trial is
efficacy of OTO-104 as measured by the reduction in number of
definitive vertigo days (DVD) in Month 3 following a single
intratympanic administration of OTO-104 compared to placebo.
Additional information about the clinical trial can be found at
www.clinicaltrials.gov.
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 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 balance and hearing
disorders. Otonomy has completed a Phase 2b trial evaluating
OTO-104 in 154 patients with unilateral Ménière's disease. Top-line
results demonstrate 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 including the count of definitive
vertigo days (DVD) that achieved statistical significance in both
Month 3 (p value = 0.030) and Month 2 (p value = 0.035). Based on
these results and discussions with the FDA during an End-of-Phase 2
meeting, Otonomy intends to conduct two parallel Phase 3 trials in
Ménière's disease using DVD during Month 3 as the primary endpoint.
The first Phase 3 trial has recently been initiated in the United
States and a second trial is expected to begin in the EU during the
first quarter of 2016. Results of both Phase 3 trials are expected
in the second half of 2017.
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 for 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 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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