Otonomy Presents Data Highlighting Potential of OTO-413, an Otic Sustained-Exposure Formulation of BDNF, to Treat Hearing Los...
November 06 2018 - 7:30AM
Society for Neuroscience Features OTO-413
Presentation as Neuroscience 2018 Hot Topic
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:SpectrumLeticia DiazVice
President202.587.2517ldiaz@spectrumscience.com
Investor Inquiries:Westwicke PartnersRobert H. UhlManaging
Director858.356.5932robert.uhl@westwicke.com
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