• OTO-413 demonstrated a higher proportion of responders than placebo based on multiple speech-in-noise hearing tests in dose escalation efficacy cohort
  

• Expansion study will support endpoint selection and powering for Phase 2

• Top-line results expected in mid-2022
  

SAN DIEGO, June 15, 2021 (GLOBE NEWSWIRE) -- Otonomy, Inc. (NASDAQ: OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, today announced the initiation of an expansion study for the Phase 1/2 clinical trial of OTO-413 in patients with speech-in-noise hearing difficulty. The randomized, double-blind, placebo-controlled study cohort will enroll approximately 30 hearing loss patients of which 20 will be treated with a single intratympanic injection of OTO-413 and 10 will receive placebo. Patients will be followed for 3 months and therapeutic activity will be assessed using the same three clinically-validated speech-in-noise hearing tests utilized in the prior cohorts: the American English Matrix phrase test, the Words-in-Noise test and the Digits-in-Noise test. Top-line results are expected in mid-2022.

“The results presented from the dose escalation efficacy cohort provide initial clinical validation of OTO-413 for the treatment of speech-in-noise hearing difficulty, which is commonly reported by patients with hearing loss due to noise exposure or aging,” said David A. Weber, Ph.D., president and CEO of Otonomy. “We are pleased to initiate this expansion study in order to demonstrate the treatment benefit in a larger cohort of hearing loss patients, continue our evaluation of multiple speech-in-noise hearing tests, and provide important information to help us design and power a more formal Phase 2 clinical trial.”

The Phase 1/2 expansion study will be conducted at multiple clinical sites in the U.S. and will enroll approximately 30 patients with self-reported hearing loss confirmed by a speech-in-noise hearing test. The primary assessment of treatment benefit will be based on the proportion of responders in the OTO-413 group versus placebo who demonstrate a clinically-meaningful level of improvement in speech-in-noise hearing from baseline to Months 2 and 3 following treatment.

About Speech-in-Noise Hearing Difficulty

Recent research has shown that the loss of synaptic connections between inner ear hair cells and auditory nerve fibers contributes to hearing impairment and may occur earlier than the loss of cochlear hair cells. This cochlear synaptopathy is proposed as an underlying pathology in age-related and noise-induced hearing loss and is 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, which can lead to social isolation, depression and early cognitive decline.

About OTO-413

OTO-413 is a proprietary, sustained-exposure formulation of brain-derived neurotrophic factor (BDNF), which is a naturally occurring protein involved in neuron growth and repair. Nonclinical studies have demonstrated that local administration of BDNF repairs the connections between inner hair cells and auditory nerve fibers in the cochlea that are damaged due to noise trauma or exposure to ototoxic chemicals. Furthermore, Otonomy has demonstrated in preclinical studies that repair of synaptic connections is associated with a restoration of hearing function. An initial dose ascending clinical trial demonstrated that a single intratympanic injection of OTO-413 was well-tolerated, and the proportion of subjects with a clinically-meaningful improvement in speech-in-noise hearing was higher in the OTO-413 treated group than placebo.

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 with a focus on 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, statements related to plans and expectations regarding OTO-413; and statements by Otonomy’s chief executive officer.

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: delays and disruption resulting from the COVID-19 pandemic; Otonomy’s ability to obtain additional financing; 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 and the nonclinical and clinical results for its product candidates, which may not support further development; the risks of the occurrence of any event, change or other circumstance that could impact the performance under or give rise to the termination of Otonomy’s collaboration or license agreements, including its collaboration agreement with AGTC, or 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; competition in the biopharmaceutical industry; Otonomy’s dependence on third parties to conduct nonclinical studies and clinical trials, and for the manufacture of its product candidates; Otonomy’s ability to protect its intellectual property in the United States and throughout the world and to ensure compliance with various laws and regulations in countries in which it conducts clinical trials; expectations regarding potential therapy benefits, 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; general economic and market conditions; 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 (SEC) on May 11, 2021, 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 H. Uhl
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