Otonomy Announces Multiple Presentations for Hearing Loss and Tinnitus Programs at Upcoming Association for Research in Otola...
February 06 2018 - 7:30AM
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.
Contacts:Media InquiriesCanale
CommunicationsHeidi Chokeir, Ph.D.Senior Vice
President619.849.5377heidi@canalecomm.com
Investor InquiriesWestwicke PartnersRobert H. UhlManaging
Director858.356.5932robert.uhl@westwicke.com
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