Otonomy Initiates Phase 1/2 Clinical Trial of OTO-313 in Tinnitus

Results expected in first half of 2020

San Diego, California, UNITED STATES

SAN DIEGO, April 11, 2019 (GLOBE NEWSWIRE) -- Otonomy, Inc. (NASDAQ: OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, today announced the initiation of a Phase 1/2 clinical trial of OTO-313, a sustained-exposure formulation of the NMDA receptor antagonist gacyclidine, in patients with tinnitus. The randomized, double-blind, placebo-controlled Phase 1/2 study will include an initial safety cohort followed by an exploratory efficacy study that will enroll approximately 50 patients with subjective tinnitus.

"Tinnitus is a common problem affecting millions of people,” said Susan Marenda King, M.D., Neurotologist and Otologist at the Ear Medical Group in San Antonio, and Clinical Professor at the University of Texas Health Science Center. “The constant annoyance of tinnitus can negatively impact a patient's quality of life by disrupting their ability to concentrate, enjoy leisure activities and obtain restful sleep. Unfortunately, we currently have no drug therapy to offer these patients. I am excited about the potential of OTO-313 and pleased to be part of the Phase 1/2 clinical trial.”

"We are excited to advance the clinical development of OTO-313 by initiating this trial, which will evaluate the therapeutic potential of OTO-313 in patients with tinnitus,” said David A. Weber, Ph.D., president and CEO of Otonomy. “We expect results from this study in the first half of 2020 and will use the information to inform the design and plan for further clinical development.”

About Tinnitus

Tinnitus is the medical term for the perception of noise when there is no sound. It is often described as a ringing in the ear but can also sound like roaring, clicking, hissing or buzzing. Approximately 10 percent of U.S. adults live with the condition, which can severely impact daily activities and often leads to anxiety and depression. Tinnitus also accounts for the most prevalent service-connected disability among veterans with an estimated cost exceeding $2 billion. There are currently no FDA approved drug treatments for tinnitus.

About OTO-313

OTO-313 is a sustained-exposure formulation of the potent and selective NMDA receptor antagonist gacyclidine in development for the treatment of tinnitus. A Phase 1 clinical safety trial was previously completed for an initial formulation of gacyclidine, with no safety concerns observed. OTO-313 is an improved formulation of gacyclidine to be administered via a single intratympanic injection.

About Otonomy

Otonomy is a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology. The company pioneered the application of drug delivery technology to the ear in order to develop products that achieve sustained drug exposure from a single local administration. This approach is covered by a broad patent estate and is being utilized to develop a pipeline of products addressing important unmet medical needs including Ménière’s disease, hearing loss, and 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 the future financial or operating performance of Otonomy. Forward-looking statements in this press release include, but are not limited to, timing of results, patient recruitment and enrollment plans, and trial design and conduct for the Phase 1/2 clinical trial for OTO-313, and statements by Otonomy’s president and CEO. 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 accurately forecast financial results;  Otonomy’s ability to obtain additional financing; Otonomy’s dependence on the regulatory success and advancement of its product candidates; 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 nonclinical 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; the risks of the occurrence of any event, change or other circumstance that could give rise to the termination of the co-promotion agreement between Otonomy and Mission; the risks of the occurrence of any event, change or other circumstance that could impact Otonomy’s ability to repay or comply with the terms of the loan provided by Oxford Finance LLC; side effects or adverse events associated with Otonomy’s product candidates; Otonomy’s ability to successfully commercialize its product candidates, if approved; competition in the biopharmaceutical industry; Otonomy’s dependence on third parties to conduct nonclinical studies and clinical trials; Otonomy’s dependence on third parties for the manufacture of its product candidates; Otonomy’s dependence on a small number of suppliers for raw materials; Otonomy’s ability to protect its intellectual property related to 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 Quarterly Report on Form 10-K filed with the Securities and Exchange Commission (the "SEC") on March 4, 2019, 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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