Otonomy Initiating Phase 1/2 Clinical Trial of OTO-413 in Hearing Loss
September 17 2019 - 7:30AM
Otonomy, Inc. (NASDAQ: OTIC), a biopharmaceutical company
dedicated to the development of innovative therapeutics for
neurotology, today announced the initiation of a Phase 1/2 clinical
trial of OTO-413, a sustained-exposure formulation of brain-derived
neurotrophic factor (BDNF), in patients with hearing loss. The
Phase 1/2 trial is a randomized, double-blind, placebo-controlled,
single ascending dose study designed to evaluate the safety and
exploratory efficacy of OTO-413 in patients with speech-in-noise
hearing difficulty.
“Recent scientific research in the neurotology field has
demonstrated that damage or loss of synaptic connections between
inner ear hair cells and spiral ganglion neurons, known as cochlear
synaptopathy, is involved in the hearing difficulty that many
people experience in a loud environment, and that this pathology
may also play a role in age-related and noise-induced hearing
loss,” said Andrea Vambutas, M.D., Director for the Center of
Hearing & Balance at the New York Head & Neck Institute.
“Repair of the synaptic connection through local administration of
a neurotrophic factor such as BDNF holds promise for patients with
speech-in-noise hearing difficulty, and this Phase 1/2 clinical
trial provides an exciting first opportunity to evaluate this
therapeutic approach.”
“Initiating this clinical trial as planned keeps us on track to
have results for three clinical programs in 2020 – the OTIVIDEX™
Phase 3 trial in Ménière’s disease in the first half of 2020, the
OTO-313 Phase 1/2 trial in tinnitus patients in the first half of
2020, and this OTO-413 Phase 1/2 trial in the second half of 2020,”
said David A. Weber, Ph.D., president and CEO of Otonomy.
“Furthermore, advancing this program into clinical development also
highlights our leadership in neurotology with clinical-stage
programs addressing hearing loss, tinnitus, and balance disorders,
the largest indications and market opportunities in this emerging
field.”
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
ribbon synapses damaged due to noise trauma or exposure to ototoxic
chemicals, and restores hearing function. The initial indication
for OTO-413 is speech-in-noise hearing difficulty, a type of
hearing loss believed to be caused by cochlear synaptopathy that
affects an estimated 9 million people in the United States. A Phase
1/2 clinical trial evaluating the safety and exploratory efficacy
of OTO-413 in patients with speech-in-noise hearing difficulty is
expected to have results in the second half of 2020.
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, timing of results, patient recruitment and
enrollment plans, and trial design and conduct for the Phase 1/2
clinical trial for OTO-413, timing of results for the OTIVIDEX
Phase 3 trial in Ménière’s disease and the OTO-313 Phase 1/2 trial
in tinnitus patients, 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; 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 August 1, 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 InquiriesSpectrum ScienceLeticia DiazVice President
202.587.2517ldiaz@spectrumscience.com
Investor InquiriesWestwicke PartnersRobert H. UhlManaging
Director858.356.5932robert.uhl@westwicke.com
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