Otonomy Initiates Expansion of Phase 1/2 Clinical Trial for OTO-413 in Hearing Loss
June 15 2021 - 7:30AM
Otonomy, Inc. (NASDAQ: OTIC), a biopharmaceutical company
dedicated to the development of innovative therapeutics for
neurotology, today announced the initiation of an expansion study
for the Phase 1/2 clinical trial of OTO-413 in patients with
speech-in-noise hearing difficulty. The randomized, double-blind,
placebo-controlled study cohort will enroll approximately 30
hearing loss patients of which 20 will be treated with a single
intratympanic injection of OTO-413 and 10 will receive placebo.
Patients will be followed for 3 months and therapeutic activity
will be assessed using the same three clinically-validated
speech-in-noise hearing tests utilized in the prior cohorts: the
American English Matrix phrase test, the Words-in-Noise test and
the Digits-in-Noise test. Top-line results are expected in
mid-2022.
“The results presented from the dose escalation
efficacy cohort provide initial clinical validation of OTO-413 for
the treatment of speech-in-noise hearing difficulty, which is
commonly reported by patients with hearing loss due to noise
exposure or aging,” said David A. Weber, Ph.D., president and CEO
of Otonomy. “We are pleased to initiate this expansion study in
order to demonstrate the treatment benefit in a larger cohort of
hearing loss patients, continue our evaluation of multiple
speech-in-noise hearing tests, and provide important information to
help us design and power a more formal Phase 2 clinical trial.”
The Phase 1/2 expansion study will be conducted at
multiple clinical sites in the U.S. and will enroll approximately
30 patients with self-reported hearing loss confirmed by a
speech-in-noise hearing test. The primary assessment of treatment
benefit will be based on the proportion of responders in the
OTO-413 group versus placebo who demonstrate a
clinically-meaningful level of improvement in speech-in-noise
hearing from baseline to Months 2 and 3 following treatment.
About Speech-in-Noise Hearing
Difficulty
Recent research has shown that the loss of synaptic
connections between inner ear hair cells and auditory nerve fibers
contributes to hearing impairment and may occur earlier than the
loss of cochlear hair cells. This cochlear synaptopathy is proposed
as an underlying pathology in age-related and noise-induced hearing
loss and is 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, which can lead to social
isolation, depression and early cognitive decline.
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 the connections between inner hair cells and auditory
nerve fibers in the cochlea that are damaged due to noise trauma or
exposure to ototoxic chemicals. Furthermore, Otonomy has
demonstrated in preclinical studies that repair of synaptic
connections is associated with a restoration of hearing function.
An initial dose ascending clinical trial demonstrated that a single
intratympanic injection of OTO-413 was well-tolerated, and the
proportion of subjects with a clinically-meaningful improvement in
speech-in-noise hearing was higher in the OTO-413 treated group
than placebo.
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-413; and statements by Otonomy’s chief
executive 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 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 Quarterly Report on Form 10-Q filed
with the Securities and Exchange Commission (SEC) on May 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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