SAN DIEGO, April 20, 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 inner and middle ear, today announced that it has achieved target enrollment in its multiple-dose safety study of OTO-104 in patients with Ménière's disease. This prospective, randomized, placebo-controlled study, designed to evaluate the safety of quarterly dosing of OTO-104, enrolled a total of 128 patients across multiple trial sites in the United Kingdom.
"We would like to thank all of the patients for their participation in this trial, and the clinical investigators for their support in rapidly meeting our enrollment goals," said David A. Weber, Ph.D., president and CEO of Otonomy. "This study will provide us with important data on the safety of quarterly dosing with OTO-104, a dosing regimen we anticipate will be relevant in the long-term treatment of Ménière's disease patients. Furthermore, we expect that the results of this trial will support future regulatory filings in this indication in conjunction with results from the ongoing Phase 2b trial for which we expect to announce results this quarter, as well as a second pivotal single-dose efficacy trial that will be initiated pending positive results."
In the first part of this multiple-dose safety study, patients are randomized to receive two doses of either placebo or 12 mg OTO-104 by intratympanic (IT) injection given at quarterly intervals. Patients completing the double-blind portion of the study will receive two IT injections of OTO-104 at quarterly intervals. Each enrolled patient is expected to participate in the study for a total of one year.
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 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 was 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 has completed enrollment with a total of 154 Ménière's disease patients, and results are 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 enrollment has recently 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 middle and inner ear following a single intratympanic 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, and a New Drug Application for AuriPro in this indication has been submitted to the FDA. 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.
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, among others, statements concerning the progress, timing and data generated from the multiple-dose safety study of OTO-104, Otonomy's belief that the results of such study will support regulatory filings in this indication, Otonomy's expectations for the timing of results with respect to the OTO-104 Phase 2b single-dose efficacy clinical trial, and Otonomy's belief that the result of such trial will serve as one of two pivotal, single-dose efficacy trials required to support U.S. regulatory approval. 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. Information regarding the foregoing and additional risks may be found in the section entitled "Risk Factors" in Otonomy's Annual Report on Form 10-K filed with the Securities and Exchange Commission (the SEC) on March 18, 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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