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Press Release

Otonomy Announces Multiple Presentations for Hearing Loss and Tinnitus Programs at Upcoming Association for Research in Otolaryngology Meeting
Data Support Potential of OTO-413 as a Treatment for Synaptopathy-Related Hearing Loss

SAN DIEGO, Feb. 06, 2018 (GLOBE NEWSWIRE) -- Otonomy, Inc. (NASDAQ:OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for otology, today announced seven data presentations related to the company's programs in hearing loss and tinnitus at the upcoming Association for Research in Otolaryngology (ARO) Annual MidWinter Meeting, February 10 to 13, 2018, in San Diego. This includes multiple presentations demonstrating the therapeutic potential of OTO-413, an otic formulation of brain-derived neurotrophic factor (BDNF), for the repair of cochlear synaptopathy and the treatment of speech-in-noise hearing difficulties affecting approximately 3% of the U.S. population1.

Otonomy's presentations related to the OTO-413 program are as follows:

  • "Effectiveness of TrkB and TrkC agonists at promoting neuron survival, neurite extension and synapse restoration in rat cochlea ex-vivo models" by Szobota et al., oral presentation on February 13 from 3-3:15 p.m. PST
  • "A sustained-exposure formulation of the neurotrophic factor BDNF protects against noise-induced cochlear synaptopathy in young adult and aged rats" by Piu et al., poster presentation on February 11 beginning at 1 p.m. PST
  • "Development of rodent models of cochlear synaptopathy and auditory neuropathy" by Barden et al., poster presentation on February 11 beginning at 1 p.m. PST

“These nonclinical results support the potential of OTO-413 for the treatment of synaptopathy-related hearing loss by showing that BDNF is active in promoting spiral ganglion neuron survival, neurite growth, and synapse repair, and by demonstrating that OTO-413 provides sustained exposure of BDNF in the inner ear from a single local administration,” said Kathie Bishop, Ph.D., chief scientific officer of Otonomy. “Results from these and other studies support our advancement of OTO-413 into development with a Phase 1/2 clinical study in hearing loss patients expected to start in the first half of 2019."

Additional poster presentations by Otonomy scientists and research collaborators include:

  • "Comparison of moderate and severe models of aminoglycoside-induced hair cell loss in cochlear explants" by Jacques et al., poster presentation on February 10 beginning at 1 p.m. PST
  • "Functional characterization of OTO-311, a sustained-exposure formulation of the NMDA receptor antagonist gacyclidine, in clinical development for the treatment of tinnitus" by Tsivkovskaia et al., poster presentation on February 12 beginning at 1 p.m. PST
  • "Perilymph pharmacokinetics compared for dexamethasone-phosphate, dexamethasone and triamcinolone with local applications" by Salt et al., poster presentation on February 12 beginning at 1 p.m. PST
  • "In vivo imaging of central auditory neurons following acute pharmacological manipulation of the cochlea" by Babola et al., poster presentation on February 12 beginning at 1 p.m. PST

In addition, David A. Weber, Ph.D., president and CEO of Otonomy will deliver an invited presentation titled "The Business, Financial and Development Path Required for Pharmacotherapy of Neurosensory Disease" during a Presidential Symposium titled "From Bench to Boardroom: Perspectives on Commercializing Research in Otolaryngology" which will be held on February 10 from 8 a.m. to 12:15 p.m. PST.

"Otonomy's multiple presentations at ARO, the premier international otolaryngology research conference, is a clear indication of the breadth and depth of our product development activities,” said Dr. Weber. “We also view the interest in discussing translational issues, including product commercialization, during the Presidential Symposium as a very healthy sign of the emerging otology market opportunity that bears comparison to the retinal treatment market before availability of FDA-approved intravitreal products."

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. This condition affects approximately 3% of the U.S. population1.

1Tremblay et al., Ear Hear (2015)

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; 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 Commssion (the "SEC") on November 8, 2017, 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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robert.uhl@westwicke.com

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Source: Otonomy, Inc.