Otonomy Successfully Completes One-Year, Multiple-Dose Clinical Safety Trial for OTO-104 in Ménière’s Disease Patients
August 01 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
successful completion of a one-year, multiple-dose clinical safety
trial of OTO-104 in patients with Ménière’s disease. This
prospective, randomized, placebo-controlled clinical safety trial
enrolled a total of 128 patients across multiple trial sites in the
United Kingdom and demonstrated that quarterly dosing of OTO-104
was well tolerated.
In the first part of this trial, patients were randomized to
receive two doses of either placebo or OTO-104 by intratympanic
(IT) injection given at a three-month, or "quarterly", interval.
Patients completing the double-blind portion of the study were
eligible to receive two IT injections of OTO-104 given at a
quarterly interval. A total of 90 patients received four quarterly
doses of OTO-104 reflecting a greater than 90% compliance rate
during the double-blind and open label portions of the trial. There
were no notable differences in treatment emergent adverse events,
audiometry or tympanometry between patients in the OTO-104 and
placebo groups. In general, the safety profile observed with
quarterly dosing of OTO-104 was comparable to that observed from
previous clinical trials with a single dose of OTO-104.
“On behalf of my fellow investigators, I would like to thank the
Ménière’s patients who participated in this year-long trial,” said
John Phillips, Consultant ENT Surgeon at the Norfolk and Norwich
University Hospital, and Coordinating Investigator of the trial.
“The high patient compliance rate, review of adverse event reports
and all safety data by the Drug Safety Monitoring Board throughout
the trial, and post-study assessment of otoscopy, audiometry and
tympanometry data supports that quarterly dosing with OTO-104 is
generally well tolerated by patients.”
“Since Ménière’s disease is a chronic disorder, the
demonstration that repeat-dosing with OTO-104 is well tolerated by
patients is an important component of our registration program,”
said David A. Weber, Ph.D., president and CEO of Otonomy.
“Furthermore, this clinical trial also provided helpful experience
with the use of OTO-104 by investigators who are now recruiting
patients in the ongoing single-dose AVERTS-2 Phase 3 efficacy
trial.”
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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