Otonomy Initiates Phase 3 Clinical Trial of OTIVIDEX™ in Ménière’s Disease
July 26 2018 - 7:30AM
Otonomy, Inc. (NASDAQ:OTIC), a biopharmaceutical company
dedicated to the development of innovative therapeutics for
otology, today announced initiation of the additional Phase 3 trial
required to support a submission for U.S. registration of OTIVIDEX
in Ménière’s disease. The company expects to have top-line results
from this trial in the first half of 2020.
“We are excited to initiate this trial for OTIVIDEX, which we
believe is the remaining clinical requirement to bring a new
treatment option to Ménière’s disease patients experiencing
debilitating vertigo episodes,” said David A. Weber, Ph.D.,
president and CEO of Otonomy. “This announcement demonstrates our
commitment to achieving our milestones and reinforces our
leadership position in the emerging otology field.”
The design and conduct of this pivotal trial is based on the
successful AVERTS-2 Phase 3 trial. This trial retains the same
primary efficacy endpoint, daily diary vertigo scale, use of a
one-month lead-in period, and primary analysis at three months
after a single treatment. The company plans to enroll approximately
160 patients, with the majority expected to be recruited in Europe
where the AVERTS-2 trial was conducted. Additional steps have been
taken to manage patient expectation bias and the placebo response
including refinement of site selection criteria, emphasizing
recruitment of well-characterized Ménière’s patients known to the
investigators, and careful management of clinical site
communication with study subjects.
About Otonomy Otonomy is a biopharmaceutical
company dedicated to the development of innovative therapeutics for
otology. The company pioneered the application of drug delivery
technology to the ear in order to develop products that achieve
sustained drug exposure from a single local administration. This
approach is covered by a broad patent estate and is being utilized
to develop a pipeline of products addressing important unmet
medical needs including Ménière’s disease, hearing loss, and
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 the future financial or operating performance of Otonomy.
Forward-looking statements in this press release include, but are
not limited to, timing of top-line results, and patient recruitment
and enrollment plans, for the Phase 3 trial for OTIVIDEX, and
statements by Otonomy’s president and CEO. 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 regulatory
success and advancement of its product candidates; 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
nonclinical 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;
Otonomy’s ability to successfully commercialize its product
candidates, if approved; competition in the biopharmaceutical
industry; Otonomy’s dependence on third parties to conduct
nonclinical studies and clinical trials; Otonomy’s dependence on
third parties for the manufacture of its product candidates;
Otonomy’s dependence on a small number of suppliers for raw
materials; Otonomy’s ability to protect its intellectual property
related to 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 Quarterly
Report on Form 10-Q filed with the Securities and Exchange
Commission (the “SEC”) on May 9, 2018, 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 InquiriesCanale CommunicationsHeidi Chokeir, Ph.D.Senior
Vice President619.849.5377heidi@canalecomm.com
Investor InquiriesWestwicke PartnersRobert H. UhlManaging
Director858.356.5932robert.uhl@westwicke.com
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