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Otonomy Initiates Phase 3 Clinical Trial of OTIVIDEX™ in Ménière’s Disease
SAN DIEGO, July 26, 2018 (GLOBE NEWSWIRE) -- 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.
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.
Heidi Chokeir, Ph.D.
Senior Vice President
Robert H. Uhl