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Otonomy Presents Data Highlighting Potential of OTO-413, an Otic Sustained-Exposure Formulation of BDNF, to Treat Hearing Loss

Society for Neuroscience Features OTO-413 Presentation as Neuroscience 2018 Hot Topic

SAN DIEGO, Nov. 06, 2018 (GLOBE NEWSWIRE) -- Otonomy, Inc. (NASDAQ: OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for otology, today is presenting data on the therapeutic potential of OTO-413, an otic sustained-exposure formulation of brain-derived neurotrophic factor (BDNF). These promising preclinical data, demonstrating the potential of intratympanic BDNF to repair cochlear synaptopathy, an underlying cause of hearing loss including speech-in-noise hearing difficulty, are being presented as part of the Society for Neuroscience (SfN) Annual Meeting in San Diego, November 3-7, 2018.

“The selection of our OTO-413 presentation as a Neuroscience 2018 Hot Topic acknowledges the increasing interest in better understanding the neuroscience of the inner ear and the importance of Otonomy’s work to address the significant unmet needs of people living with hearing loss as well as other burdensome otologic conditions, such as Ménière’s disease, and tinnitus,” said Kathie Bishop, Ph.D., chief scientific officer of Otonomy. “These data, showing that OTO-413 improves measures of cochlear synaptopathy, support our ongoing activities to initiate a Phase 1/2 clinical trial in people with speech-in-noise hearing loss in 2019.”

Recent scientific advances have shown that the loss of synaptic connections between inner ear hair cells and spiral ganglion neurons contributes to hearing impairment. This cochlear synaptopathy is proposed as an underlying pathology in age-related and noise-induced hearing loss and is also believed to contribute to the common difficulty of hearing speech in the presence of background noise. Overall, there are more than 50 million people in the U.S. with acquired hearing loss including a significant proportion experiencing speech-in-noise hearing difficulty. Results from these studies demonstrated that a single intratympanic administration of OTO-413 provided sustained-exposure of BDNF to the inner ear and that OTO-413 improved both the structural and functional deficits of cochlear synaptopathy in an animal model.

“Hearing loss can have a profound impact on individuals’ daily lives and contributes to impaired social, psychological, and cognitive function. As the population ages and noise exposure in our society steadily increases, understanding and treating hearing loss is one of the most important efforts of our time,” said Barbara Shinn-Cunningham, Ph.D., Director, Carnegie Mellon Neuroscience Institute and Professor, Center for the Neural Basis of Cognition, Biomedical Engineering, Psychology, and Electrical & Computer Engineering at Carnegie Mellon University. “Over the last decade, extensive evidence from both preclinical and clinical studies has revealed that a loss or dysfunction of synaptic connections plays an important role in the pathophysiology of hearing loss. This kind of hearing loss, which can come about from aging and noise exposure, seems to manifest especially in difficulties understanding speech in noisy, social settings, which in turn leads to social isolation, depression and early cognitive decline. Recognition by the Society for Neuroscience of cochlear synaptopathy as a Hot Topic at this year's annual meeting signals the practical importance of hearing loss for everyday function and the exciting potential of treatment through synaptic repair.”

About OTO-413

OTO-413 is a proprietary, sustained-exposure formulation of brain-derived neurotropic factor (BDNF) which is a naturally occurring protein involved in neuron growth and repair. Nonclinical studies by Otonomy and other research groups have demonstrated that local administration of BDNF repairs ribbon synapses damaged due to noise trauma or exposure to ototoxic chemicals and restores hearing function. Otonomy has initiated nonclinical studies and manufacturing for OTO-413 to support an Investigational New Drug (IND) Application, with a Phase 1/2 clinical trial expected to begin in hearing loss patients in the first half of 2019. The initial indication for OTO-413 will be patients with synaptopathy-related hearing loss that is characterized by speech-in-noise hearing difficulty.

About Otonomy

Otonomy is a biopharmaceutical company dedicated to the development of innovative therapeutics for otology. 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, the timing of the OTO-413 Phase 1/2 clinical study in hearing loss patients. 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 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; 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-Q filed with the Securities and Exchange Commission (the “SEC”) on November 5, 2018, 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.

Contacts:

Media Inquiries:
Spectrum
Leticia Diaz
Vice President
202.587.2517
ldiaz@spectrumscience.com

Investor Inquiries:
Westwicke Partners
Robert H. Uhl
Managing Director
858.356.5932
robert.uhl@westwicke.com

Tuesday, November 6, 2018 - 07:30

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