SAN DIEGO, March 23, 2016 (GLOBE NEWSWIRE) -- Otonomy, Inc. (Nasdaq:OTIC), a 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 patient in the OTO-104 Phase 3 clinical trial in Ménière’s disease patients in the European Union (EU). This trial has been named AVERTS-2 (Alleviation of Vertigo Episodes Study) with the ongoing U.S. trial called AVERTS-1.
“Initiation of the AVERTS-2 trial for OTO-104 in Ménière’s disease, as planned, allows these two identical Phase 3 trials to proceed in parallel and keeps us on track with our goal of having results in the second half of 2017,” said David A. Weber, Ph.D., president and CEO of Otonomy. “Conducting this second trial in the EU also enables us to establish a core clinician base outside the U.S. to further our global development and commercialization efforts.”
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 EU. 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 is a sustained-exposure formulation of the steroid dexamethasone in development for the treatment of various severe balance and hearing disorders. The first indication being pursued is Ménière's disease, which is a chronic condition characterized by acute vertigo attacks, tinnitus, fluctuating hearing loss and a feeling of aural fullness. Based on supportive results from a Phase 2b trial, Otonomy has initiated two Phase 3 trials, AVERTS-1 in the United States and AVERTS-2 in the European Union. Results of both Phase 3 trials are expected in the second half of 2017. OTO-104 has been granted Fast Track designation for this indication by the FDA. Otonomy also intends to initiate clinical development for OTO-104 in a second indication, the prevention of hearing loss associated with cisplatin chemotherapy. Otonomy expects to initiate a Phase 2 feasibility clinical trial for OTO-104 in this indication in the second half of 2016.
Otonomy is a biopharmaceutical company focused on the development and commercialization of innovative therapeutics for diseases and disorders of the ear. OTIPRIO (ciprofloxacin otic suspension) is approved in the United States for use during tympanostomy tube placement surgery in pediatric patients, and commercial launch commenced in March 2016. OTO-104 is a steroid in development for the treatment of Ménière's disease and other severe balance and hearing disorders. Two Phase 3 trials in Ménière's disease patients are underway, with results expected during the second half of 2017. OTO-311 is an NMDA receptor antagonist for the treatment of tinnitus that is in a Phase 1 clinical safety trial. Otonomy’s proprietary formulation technology utilizes a thermosensitive gel and drug microparticles to enable single dose treatment by a physician. 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, the timing of the OTO-104 Phase 2 feasibility clinical trial for cisplatin-induced hearing loss, and the timing of results for the two OTO-104 Phase 3 clinical trials 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 commercial success of OTIPRIO and the regulatory success and advancement of additional product candidates, such as OTO-104 and 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, 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 OTIPRIO and product candidates; Otonomy's dependence on a small number of suppliers for raw materials; Otonomy's ability to protect its intellectual property related to OTIPRIO and 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 Annual Report on Form 10-K filed with the Securities and Exchange Commission (the "SEC") on March 7, 2016, 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.
Heidi Chokeir, Ph.D.
Senior Vice President
Robert H. Uhl