Otonomy Presents Preclinical Results for GJB2 Gene Therapy Collaboration and Cisplatin Otoprotection Program
January 28 2020 - 7:30AM
Otonomy, Inc. (Nasdaq: OTIC), a biopharmaceutical company
dedicated to the development of innovative therapeutics for
neurotology, today announced preclinical results from the company’s
gene therapy collaboration with Applied Genetic Technologies
Corporation (Nasdaq: AGTC) focused initially on treating GJB2
deficiency for congenital hearing loss, and preclinical results
demonstrating the therapeutic potential of a class of compounds
being evaluated for otoprotection against cisplatin-induced hearing
loss (CIHL). These results were presented during the ongoing
Association for Research in Otolaryngology (ARO) 43rd Annual
MidWinter Meeting being held in San Jose, California.
“Together with our strategic partner, AGTC, we are encouraged by
these initial preclinical results that demonstrate our ability to
express a gene of interest in the target cells relevant to the
treatment of congenital hearing loss due to GJB2 deficiency," said
David A. Weber, Ph.D., president and chief executive officer of
Otonomy. “Also, the preclinical results presented for our OTO-510
program highlight the therapeutic potential of a novel class of
cisplatin-binding molecules for protection against CIHL and the
higher potency of these agents versus other molecules currently in
clinical development.”
Preclinical Results for GJB2 Gene Therapy Collaboration
In October 2019, Otonomy and AGTC announced a strategic
collaboration to co-develop and co-commercialize an AAV-based gene
therapy to restore hearing in patients with sensorineural hearing
loss caused by a mutation in the gap junction protein beta 2 gene
(GJB2) -- the most common cause of congenital hearing loss. The
joint presentation by Otonomy and AGTC at ARO provided initial
demonstration that a gene of interest can be expressed in support
cells of the cochlea, which are the relevant target cells for
treating GJB2 deficiency, using novel and proprietary AAV capsids.
Furthermore, these studies identified several capsids with
favorable tropism and gene expression level in support cells
compared to previously reported capsids used in the field.
Importantly, none of the novel AAV capsids evaluated for further
development exhibited signs of cellular toxicity.
Preclinical Results for OTO-510 Otoprotection Program
Cisplatin is a potent chemotherapeutic agent that is widely used
to treat a variety of cancers in adults and children.
Unfortunately, the administration of cisplatin is commonly
associated with severe adverse effects including CIHL that is
progressive, bilateral and irreversible. At ARO, Otonomy presented
preclinical results demonstrating varying degrees of otoprotection
against CIHL for several different classes of therapeutic agents.
In particular, a novel proprietary class of agents that potently
bind to cisplatin demonstrated greater otoprotection than
anti-oxidant and anti-apoptotic molecules, and increased potency
relative to other cisplatin-binding molecules currently in clinical
development. These results highlight the therapeutic potential of
Otonomy’s novel otoprotectant agents as the basis for the OTO-510
program for CIHL.
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 expectations regarding the potential benefits,
development activity and advancement of preclinical programs; the
potential benefits of and activity under the collaboration
agreement between AGTC and Otonomy, including but not limited to
development activity; 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 collaboration agreement between
AGTC and Otonomy; 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 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; 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, 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.
Contacts:
Media Inquiries:Spectrum ScienceChloé-Anne RamseyVice
President404.865.3601 cramsey@spectrumscience.com
Investor Inquiries:Westwicke ICRRobert H. UhlManaging
Director858.356.5932robert.uhl@westwicke.com
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