SAN DIEGO, Nov. 18, 2015 (GLOBE NEWSWIRE) -- Otonomy, Inc. (Nasdaq:OTIC), a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapeutics for diseases and disorders of the ear, today announced the enrollment of the first patients in the U.S. Phase 3 clinical trial of OTO-104 in Ménière's disease. A second Phase 3 trial is expected to be initiated in the EU in the first quarter of 2016.
"Initiation of Phase 3 for OTO-104 in Ménière's disease marks an important milestone for this program and for our company whose founder suffers from this debilitating vertigo disorder," said David A. Weber, Ph.D., president and CEO of Otonomy. "We look forward to leveraging the valuable lessons we learned from our Phase 2b trial and reviewed during our End-of-Phase 2 meeting with the FDA, to successfully implement this Phase 3 program with a goal of providing results in the second half of 2017."
The 16-week, prospective, randomized, double-blind, placebo-controlled Phase 3 trial will enroll approximately 160 patients with unilateral Ménière's disease at multiple clinical sites in the United States. The primary endpoint of the trial is efficacy of OTO-104 as measured by the reduction in number of definitive vertigo days (DVD) in Month 3 following a single intratympanic administration of OTO-104 compared to placebo. Additional information about the clinical trial can be found at www.clinicaltrials.gov.
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.
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 balance and hearing disorders. Otonomy has completed a Phase 2b trial evaluating OTO-104 in 154 patients with unilateral Ménière's disease. Top-line results demonstrate that OTO-104 narrowly missed the primary efficacy endpoint (p=0.067) but achieved statistical significance (p<0.05) for multiple prospectively defined secondary vertigo endpoints at multiple time points including the count of definitive vertigo days (DVD) that achieved statistical significance in both Month 3 (p value = 0.030) and Month 2 (p value = 0.035). Based on these results and discussions with the FDA during an End-of-Phase 2 meeting, Otonomy intends to conduct two parallel Phase 3 trials in Ménière's disease using DVD during Month 3 as the primary endpoint. The first Phase 3 trial has recently been initiated in the United States and a second trial is expected to begin in the EU during the first quarter of 2016. Results of both Phase 3 trials are expected in the second half of 2017.
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 ear following a single administration. Otonomy has three product candidates in development. OTIPRIO™ 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 the FDA has assigned a PDUFA action date of December 25, 2015 for the company's New Drug Application. OTO-104 is a steroid in development for the treatment of Ménière's disease and other balance and hearing disorders. A Phase 3 trial for Ménière's disease patients has been initiated in the United States with a second trial expected to begin in the EU during the first quarter of 2016. OTO-311 is an NMDA receptor antagonist for the treatment of tinnitus that is in a Phase 1 clinical safety trial. 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 future financial or operating performance of Otonomy. Forward-looking statements in this press release include, but are not limited to, Otonomy's expectations regarding the timing of the Phase 3 clinical trials for OTO-104. 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 substantial additional financing; Otonomy's dependence on the regulatory and commercial success of OTIPRIO and OTO-104 and advancing additional product candidates, such as OTO-311; 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; competition in the biopharmaceutical 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; 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 November 10, 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.
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