Otonomy Completes Enrollment of OTO-104 Multiple-Dose Safety Study in Meniere's Disease Patients
April 20 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 inner and
middle ear, today announced that it has achieved target enrollment
in its multiple-dose safety study of OTO-104 in patients with
Ménière's disease. This prospective, randomized, placebo-controlled
study, designed to evaluate the safety of quarterly dosing of
OTO-104, enrolled a total of 128 patients across multiple trial
sites in the United Kingdom.
"We would like to thank all of the patients for their
participation in this trial, and the clinical investigators for
their support in rapidly meeting our enrollment goals," said David
A. Weber, Ph.D., president and CEO of Otonomy. "This study will
provide us with important data on the safety of quarterly dosing
with OTO-104, a dosing regimen we anticipate will be relevant in
the long-term treatment of Ménière's disease patients. Furthermore,
we expect that the results of this trial will support future
regulatory filings in this indication in conjunction with results
from the ongoing Phase 2b trial for which we expect to announce
results this quarter, as well as a second pivotal single-dose
efficacy trial that will be initiated pending positive
results."
In the first part of this multiple-dose safety study, patients
are randomized to receive two doses of either placebo or 12 mg
OTO-104 by intratympanic (IT) injection given at quarterly
intervals. Patients completing the double-blind portion of the
study will receive two IT injections of OTO-104 at quarterly
intervals. Each enrolled patient is expected to participate in the
study for a total of one year.
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 completed a randomized, prospective, double-blind,
placebo-controlled, Phase 1b clinical trial of a single IT
injection of OTO-104 in patients with Ménière's disease. Results
demonstrated that OTO-104 was well tolerated when administered as a
single IT injection, and 12 mg of OTO-104 was associated with
clinically meaningful improvements in both vertigo frequency and
tinnitus compared to placebo three months after treatment. There
were no serious adverse events observed during the clinical trial.
A Phase 2b single-dose efficacy trial has completed enrollment with
a total of 154 Ménière's disease patients, and results are expected
in the second quarter of 2015. The company believes this trial will
serve as one of two pivotal, single-dose efficacy trials required
to support U.S. regulatory approval. 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 recently 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 middle and
inner ear following a single intratympanic injection. 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 a New Drug Application for AuriPro in this indication
has been submitted to the FDA. OTO-104 is a steroid that is in the
first of two pivotal clinical studies for the treatment of patients
with Ménière's disease. OTO-311 is an NMDA receptor antagonist in
development as a treatment for tinnitus. For additional information
please visit www.otonomy.com.
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, among
others, statements concerning the progress, timing and data
generated from the multiple-dose safety study of OTO-104, Otonomy's
belief that the results of such study will support regulatory
filings in this indication, Otonomy's expectations for the timing
of results with respect to the OTO-104 Phase 2b single-dose
efficacy clinical trial, and Otonomy's belief that the result of
such trial will serve as one of two pivotal, single-dose efficacy
trials required to support U.S. regulatory approval. 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.
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 18, 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.
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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