Otonomy Initiates Patient Enrollment in Second Phase 3 Clinical Trial of OTO-104 in Ménière’s Disease
March 23 2016 - 7:30AM
Otonomy, Inc. (Nasdaq:OTIC), a 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 patient in the OTO-104 Phase 3 clinical
trial in Ménière’s disease patients in the European Union (EU).
This trial has been named AVERTS-2 (Alleviation of Vertigo Episodes
Study) with the ongoing U.S. trial called AVERTS-1.
“Initiation of the AVERTS-2 trial for OTO-104 in
Ménière’s disease, as planned, allows these two identical Phase 3
trials to proceed in parallel and keeps us on track with our goal
of having results in the second half of 2017,” said David A. Weber,
Ph.D., president and CEO of Otonomy. “Conducting this second trial
in the EU also enables us to establish a core clinician base
outside the U.S. to further our global development and
commercialization efforts.”
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 EU. 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 is a sustained-exposure formulation of the
steroid dexamethasone in development for the treatment of various
severe balance and hearing disorders. The first indication being
pursued is Ménière's disease, which is a chronic condition
characterized by acute vertigo attacks, tinnitus, fluctuating
hearing loss and a feeling of aural fullness. Based on supportive
results from a Phase 2b trial, Otonomy has initiated two Phase 3
trials, AVERTS-1 in the United States and AVERTS-2 in the European
Union. Results of both Phase 3 trials are expected in the second
half of 2017. OTO-104 has been granted Fast Track designation for
this indication by the FDA. Otonomy also intends to initiate
clinical development for OTO-104 in a second indication, the
prevention of hearing loss associated with cisplatin chemotherapy.
Otonomy expects to initiate a Phase 2 feasibility clinical trial
for OTO-104 in this indication in the second half of 2016.
About Otonomy
Otonomy is a biopharmaceutical company focused
on the development and commercialization of innovative therapeutics
for diseases and disorders of the ear. OTIPRIO (ciprofloxacin otic
suspension) is approved in the United States for use
during tympanostomy tube placement surgery in pediatric patients,
and commercial launch commenced in March 2016. OTO-104 is a steroid
in development for the treatment of Ménière's disease and other
severe balance and hearing disorders. Two Phase 3 trials in
Ménière's disease patients are underway, with results expected
during the second half of 2017. OTO-311 is an NMDA receptor
antagonist for the treatment of tinnitus that is in a Phase 1
clinical safety trial. Otonomy’s proprietary formulation technology
utilizes a thermosensitive gel and drug microparticles to enable
single dose treatment by a physician. 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, the timing of the OTO-104 Phase 2
feasibility clinical trial for cisplatin-induced hearing loss, and
the timing of results for the two OTO-104 Phase 3 clinical trials
in Ménière's disease. 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 additional financing; Otonomy's
dependence on the commercial success of OTIPRIO and the regulatory
success and advancement of additional product candidates, such as
OTO-104 and 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, 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 OTIPRIO and product
candidates; Otonomy's dependence on a small number of suppliers for
raw materials; Otonomy's ability to protect its intellectual
property related to OTIPRIO and its 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 Annual Report on Form 10-K filed with the
Securities and Exchange Commission (the "SEC") on March 7, 2016,
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.
Contacts:
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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