Otonomy and AGTC to Present Preclinical Proof-of-Concept Results for OTO-825 Gene Therapy at ASGCT Annual Meeting
April 28 2021 - 7:30AM
Otonomy, Inc. (Nasdaq: OTIC), a biopharmaceutical company
dedicated to the development of innovative therapeutics for
neurotology, today announced the upcoming presentation of
preclinical proof-of-concept data for OTO-825 at the American
Society of Gene & Cell Therapy (ASGCT) Annual Meeting on May
13, 2021. OTO-825 is the clinical candidate targeting the gap
junction beta-2 (GJB2) gene developed under the company’s
collaboration with Applied Genetic Technologies Corporation
(Nasdaq: AGTC). Mutations in the GJB2 gene are the most common
cause of congenital hearing loss and typically result in moderate
to severe hearing impairment.
"We are excited to present these preclinical results for OTO-825
that build on our previous presentations demonstrating gene
expression in support cells of the cochlear, which are the target
cells for GJB2 gene therapy, using novel AAV vectors identified
through our collaboration with AGTC,” said Alan C. Foster, Ph.D.,
chief scientific officer of Otonomy. “Based on these encouraging
results that demonstrate hearing recovery and improved cochlear
morphology following OTO-825 administration, the companies have
initiated IND-enabling activities and look forward to providing
additional details of the program in the next several months.”
The oral presentation entitled “AAV-mediated GJB2 gene therapy
rescues hearing loss and cochlear damage in a mouse model of
congenital hearing loss caused by conditional Connexin26 knockout”
by Mathur et al., will be presented on May 13 at 6:30 p.m. EDT.
About OtonomyOtonomy 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-825; and statements by Otonomy’s chief scientific
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, co-promotion 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 Annual Report on Form 10-K filed with
the Securities and Exchange Commission (SEC) on February 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.
Contacts:
Media InquiriesSpectrum ScienceChloé-Anne RamseyVice
President404.865.3601cramsey@spectrumscience.com
Investor InquiriesWestwicke ICRRobert H. UhlManaging
Director858.356.5932robert.uhl@westwicke.com
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