Positive Results from AVERTS-2 Phase 3 Clinical Trial will Support Submission for U.S. Registration and Provide Basis for Ongoing Additional Phase 3 Trial
SAN DIEGO, Oct. 02, 2018 (GLOBE NEWSWIRE) -- Otonomy, Inc. (NASDAQ: OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for otology, today announced that previously reported positive results from the AVERTS-2 Phase 3 clinical trial of OTIVIDEX in patients with Ménière’s disease will be presented in a podium presentation at the annual meeting of the American Academy of Otolaryngology - Head and Neck Surgery Foundation (AAO-HNSF) to be held in Atlanta from October 7-10.
John Phillips, FRCS (ORL-HNS), Consultant Otolaryngologist at Norfolk & Norwich University Hospitals in the United Kingdom, will present the AVERTS-2 clinical trial results on Tuesday, October 9 at 1:27 p.m. EDT. The AVERTS-2 trial achieved its primary endpoint, count of definitive vertigo days (DVD) by Poisson Regression analysis in Month 3 (p value = 0.029), based on analysis of all 174 patients enrolled in the trial. This endpoint, as well as a number of additional efficacy endpoints, were statistically significant (p value < 0.05) for patients who were enrolled in the AVERTS-2 trial through Month 3 at the time of study termination.
"I am pleased to present the results from the AVERTS-2 trial, which is the first large-scale, randomized, placebo-controlled clinical trial to demonstrate a statistically significant improvement of vertigo in Ménière’s disease patients," said Mr. Phillips. "Furthermore, the treatment benefit experienced by patients following a single intratympanic administration of OTIVIDEX was clinically meaningful with the group demonstrating a 6.2 day reduction in the mean reported number of DVD from baseline to Month 3 and a 2.5 day mean improvement compared to the placebo group in Month 3."
Otonomy believes that the AVERTS-2 trial will serve as one of two successful pivotal studies required to support the U.S. registration of OTIVIDEX in Ménière’s disease, based on a Type C meeting held with the U.S. Food and Drug Administration (FDA) in the first quarter of 2018. The second required study was initiated in July 2018 with top-line results expected in the first half of 2020. The design and conduct of this additional trial is based on the AVERTS-2 trial including 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 positive AVERTS-2 trial results and the consistency of those results to the Phase 1b and 2b studies provide robust support for the current trial,” said Anthony A. Mikulec, M.D., MBA, Professor, Chief of Otology and Neurotology, Saint Louis University School of Medicine. “The company has also learned important lessons from the AVERTS-1 trial regarding the need to manage patient expectation bias in order to control the placebo response. One way this is being addressed is through careful attention to patient communication, a change that has been well-received by investigators and clinical study staff in the ongoing Phase 3 trial."
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 expectations for the Phase 3 trial for OTIVIDEX and the Company’s belief that the AVERTS-2 trial will serve as one of the two successful pivotal studies required to support the U.S. registration of OTIVIDEX 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 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 August 8, 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.
Robert H. Uhl
Source: Otonomy, Inc.