Otonomy Completes Patient Enrollment for Phase 3 Trial of OTIVIDEX® in Ménière’s Disease
October 02 2020 - 7:30AM
Otonomy, Inc. (Nasdaq: OTIC), a biopharmaceutical company
dedicated to the development of innovative therapeutics for
neurotology, today announced the completion of patient enrollment
in the Phase 3 clinical trial of OTIVIDEX in Ménière’s disease. A
total of 149 patients have been enrolled in the trial, exceeding
the target of 142 patients. Following randomization to treatment
with a single intratympanic injection of OTIVIDEX or placebo,
patients are followed for three months.
“Completion of enrollment is an important milestone for the
OTIVIDEX program and keeps us on track for announcing results in
the first quarter of 2021. With positive results from this trial
and the positive AVERTS-2 trial results already in-hand, we would
expect to submit a New Drug Application in the third quarter of
2021,” said David A. Weber, Ph.D., president and CEO of Otonomy.
“We are grateful to the patients and investigators participating in
this trial. We also appreciate the high compliance that continues
to be demonstrated by patients in reporting their daily vertigo
episodes, which we believe reflects the high disease burden and
unmet medical need of Ménière’s disease patients.”
About OtonomyOtonomy is a biopharmaceutical
company dedicated to the development of innovative therapeutics for
neurotology. 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 statements relating to the timing and announcement
of results and conduct of, and activity for the ongoing Phase 3
clinical trial of OTIVIDEX in Ménière’s disease; expectations
regarding submission of a New Drug Application; 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: delays and disruption resulting from
the COVID-19 pandemic and governmental responses to the
pandemic, including current and future impacts to Otonomy’s
operations, the manufacturing of its product candidates, the
progression of its current clinical trials, and patient conduct and
compliance; 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, and challenges related to patient enrollment,
conduct and compliance in clinical trials; the integrity of
patient-reported outcomes in clinical trials; side effects or
adverse events associated with Otonomy’s product candidates;
Otonomy’s dependence on third parties to conduct nonclinical
studies and clinical trials; expectations regarding potential
therapy benefits; 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 August
4, 2020, 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 InquiriesSpectrum ScienceChloé-Anne RamseyVice
President404.865.3601cramsey@spectrumscience.com
Investor InquiriesWestwicke ICRRobert H. UhlManaging
Director858.356.5932robert.uhl@westwicke.com
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