Otonomy Initiates Phase 2 Clinical Trial of OTO-313 in Tinnitus
March 25 2021 - 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 2 clinical
trial of OTO-313 in patients with unilateral tinnitus. The
randomized, double-blind, placebo-controlled Phase 2 study will
enroll approximately 140 patients with persistent, early onset
tinnitus of at least moderate severity. Following the successful
Phase 1/2 trial, the primary efficacy endpoint will be a responder
analysis based on the proportion of patients reporting a clinically
meaningful improvement in TFI from baseline to both Month 1 and
Month 2 following treatment. Top-line results are expected in
mid-2022.
"Tinnitus is a common problem that negatively impacts millions
of people by disrupting their ability to sleep, concentrate at
work, and enjoy leisure activities. This often leads to anxiety and
depression that can be quite severe, as sadly reported in a recent
case of a prominent post-COVID patient experiencing unrelenting
tinnitus,” said David A. Weber, Ph.D., president and CEO of
Otonomy. “Unfortunately, there are no approved drug treatments for
tinnitus and current therapy focuses on coping and masking
mechanisms. OTO-313 was designed to address the underlying
pathology producing the false perception of sound, with the Phase
1/2 trial demonstrating a clinically meaningful reduction in
tinnitus severity in a group of responders. We are excited to be
initiating the trial and advancing the OTO-313 program for this
important unmet need.”
The Phase 2 trial will be conducted at approximately 50 clinical
sites in the U.S. and Europe. Following a lead-in period, patients
will be randomized to a single intratympanic injection of OTO-313
or placebo and then followed for four months. Consistent with the
Phase 1/2 trial results, the primary endpoint will be a responder
analysis based on the reduction in TFI score from baseline to both
Month 1 and Month 2 following treatment. In order to assess
durability of the treatment benefit, patients will be followed for
an additional two months. Other measures of efficacy include
tinnitus loudness, tinnitus annoyance, and patient global
impression of change.
About Tinnitus
Tinnitus is the medical term for the perception of noise when
there is no sound. It is often described as a ringing in the ear
but can also sound like roaring, clicking, hissing or buzzing.
Tinnitus is often caused by cochlear injury due to excessive noise,
physical trauma, persistent ear infection or exposure to an
ototoxic agent, leading to over-activation of auditory nerve fibers
and the perception of noise in the absence of an external stimulus.
Approximately 10 percent of U.S. adults suffer from the condition,
which can severely impact daily activities and result in anxiety
and depression. Tinnitus also accounts for the most prevalent
service-connected disability among veterans with an estimated cost
exceeding $2 billion. There are currently no FDA approved drug
treatments for tinnitus.
About OTO-313
OTO-313 is a sustained-exposure formulation of the potent and
selective N-Methyl-D-Aspartate (NMDA) receptor antagonist
gacyclidine. We believe that gacyclidine can reduce the severity of
tinnitus symptoms following cochlear injury by decreasing the
over-activation of damaged auditory nerve fibers in the cochlea and
their connections. OTO-313 utilizes a novel, patent-protected
formulation technology to provide several weeks of gacyclidine drug
exposure in the inner ear following a single intratympanic
injection. In 2020, we reported positive results from a Phase 1/2
trial of OTO-313 in patients with unilateral tinnitus of at least
moderate severity. This trial demonstrated a positive clinical
response for OTO-313 using the Tinnitus Functional Index (TFI) that
was correlated with improvements in tinnitus loudness, tinnitus
annoyance and patient global impression of change measures.
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 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, statements related to plans and expectations
regarding OTO-313, including with respect to patient populations
and the Phase 2 trial of OTO-313; anticipated timing of topline
results of the Phase 2 clinical trial of OTO-313; 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: delays
and disruption resulting from the COVID-19 pandemic and
governmental and site responses to the pandemic, including current
and future impacts to Otonomy’s operations, the manufacturing of
its product candidates, the progression of its current clinical
trials, and patient conduct and compliance; 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, conduct and compliance in clinical trials; the
integrity of patient-reported outcomes in its current and future
clinical trials; 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,
co-promotion or license agreements, 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 Annual Report on Form 10-K filed with
the Securities and Exchange Commission (SEC) on February 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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