SAN DIEGO, Dec. 1, 2014 (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 inner and middle ear, today announced that the company has achieved target enrollment in its Phase 2b clinical trial of OTO-104 in patients with Ménière's disease.
This prospective, randomized, double-blind, placebo-controlled study is designed to assess the efficacy and safety of OTO-104 for the treatment of Ménière's disease in a total of 140 patients. In the Phase 2b clinical trial, patients are observed for up to four months following a single intratympanic (IT) injection of either OTO-104 or placebo. The primary endpoint, consistent with the previous Phase 1b clinical trial, is the reduction in vertigo frequency during Month 3 following treatment compared to a one month baseline period. The clinical trial has been designed and is being conducted to serve as one of two pivotal, single-dose efficacy trials that the company expects the FDA will require to support a New Drug Application (NDA) filing for treatment of Ménière's disease.
"We would like to thank the patients for their participation, and the clinical investigators for their support in achieving our enrollment goal for this trial," said David A. Weber, Ph.D., president and CEO of Otonomy. "A number of potential subjects are still completing the one month lead-in period of the trial, which could result in total enrollment that will exceed 140. We continue to expect results in the second quarter of 2015."
OTO-104, which has been granted Fast Track designation by the 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 completed a randomized, prospective, double-blind, placebo-controlled, Phase 1b clinical trial of a single IT injection of OTO-104 in patients with Ménière's disease. Results demonstrated that OTO-104 is well tolerated when administered as a single IT injection, and 12 mg of OTO-104 was associated with clinically meaningful improvements in both vertigo frequency and tinnitus compared to placebo three months after treatment. There were no serious adverse events observed during the clinical trial. A Phase 2b single-dose efficacy trial with approximately 140 Ménière's disease patients is ongoing in the U.S. and Canada, with results expected in the second quarter of 2015. The company believes this trial will serve as one of two pivotal, single-dose efficacy trials required to support U.S. regulatory approval. OTO-104 is also being evaluated in a multiple-dose safety study in the United Kingdom in patients with Ménière's disease, and the company expects the results of which will support regulatory filings in this indication.
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 middle and inner ear following a single intratympanic (IT) injection. 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. OTO-104 is a steroid that is in the first of two pivotal clinical studies for the treatment of patients with Ménière's disease. 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 Statement
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements in this press release include, but are not limited to, the expected enrollment and timing of the results for Otonomy's single-dose Phase 2b clinical trial of OTO-104, Otonomy's belief that the single-dose Phase 2b clinical trial of OTO-104 will serve as one of two pivotal, single-dose efficacy trials required to support an NDA filing for the treatment of Ménière's disease and U.S. regulatory approval, the number of clinical trials with OTO-104 required by the FDA for U.S. regulatory approval, and the Company's expectation that the multiple-dose safety study of OTO-104 in the United Kingdom in patients with Ménière's disease will support regulatory filings in this indication. Forward-looking statements reflect the Company's current views with respect to certain current and future events and are subject to various risks and uncertainties that could cause actual results to differ materially. Risks and uncertainties include, but are not limited to: expectations regarding clinical trial results for existing product candidates, future development of product candidates for additional indications, and future development of other product candidates; timing and likelihood of regulatory filings and approvals; expectations regarding adoption and use of product candidates by physicians; Otonomy's ability to protect its intellectual property related to product candidates in the United States and throughout the world; Otonomy's ability to manage operating expenses, capital requirements and additional financing needs; implementation of Otonomy's business model and strategic plans for its business, products and technology; Otonomy's dependence on third parties for development, manufacture and distribution of products; and other risks. Information regarding the foregoing and additional risks may be found in the section entitled "Risk Factors" in Otonomy's Form 10-Q filed on November 12, 2014 with the Securities and Exchange Commission (the SEC), the final prospectus related to Otonomy's initial public offering filed with the SEC on August 13, 2014, 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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