SAN DIEGO, Sept. 9, 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 that it has successfully completed an End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) for OTO-104 in the treatment of Ménière's disease. As a result, the company reiterates its prior guidance given in the second quarter earnings release that it expects to initiate two parallel Phase 3 trials for OTO-104 in Ménière's patients, with the first trial expected to begin by the end of 2015 and the second trial expected to begin during the first quarter of 2016.
"We are pleased with the outcome of our meeting with the FDA and have reached agreement around endpoints as well as other important aspects for the design of our two Phase 3 trials," said David A. Weber, Ph.D., president and CEO of Otonomy. "We look forward to sharing details of these trials as well as providing a comprehensive update of our entire product pipeline at our upcoming investor and analyst day in New York on October 7, 2015."
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 inner ear conditions. Otonomy has recently completed a randomized, prospective, double-blind, placebo-controlled single-dose Phase 2b trial in a total of 154 Ménière's disease patients. Top-line results indicate 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. Based on these results Otonomy intends to initiate two parallel Phase 3 trials, with one of the trials expected to begin by the end of 2015 and the second trial expected to begin during the first quarter of 2016. OTO-104 is also being evaluated in a multiple-dose safety study in the United Kingdom in patients with Ménière's disease, and enrollment has been completed with a total of 128 patients.
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.
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. AuriPro™ 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 that has completed a Phase 2b clinical trial in 154 patients with Ménière's disease. Based on these results, Otonomy intends to initiate two parallel Phase 3 trials for OTO-104 in Ménière's disease patients with at least one trial initiated by the end of 2015. OTO-311 is an NMDA receptor antagonist in development as a treatment for 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 Otonomy's future financial or operating performance. Forward-looking statements in this press release include, but are not limited to, the initiation, timing and design of Otonomy's Phase 3 clinical trials with 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: 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; developments related to competitors and the 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; and other risks. Otonomy undertakes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law.
The factors referred to above that could cause the Company's results to differ materially from those expressed or implied by such forward-looking statements also include the risks, uncertainties and assumptions discussed from time to time in the Company's public filings and public announcements, including the Company's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission ("SEC") on August 12, 2015, and Otonomy's future reports to be filed with the SEC.
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