Otonomy Completes Enrollment in Phase 2 Clinical Trial of OTO-313 in Tinnitus
February 22 2022 - 7:30AM
Otonomy, Inc. (NASDAQ: OTIC), a biopharmaceutical company
dedicated to the development of innovative therapeutics for
neurotology, today announced the completion of patient enrollment
in the Phase 2 clinical trial of OTO-313 in tinnitus.
The randomized, double-blind, placebo-controlled trial enrolled
153 patients with persistent, unilateral tinnitus of at least
moderate severity (target enrollment was 140 patients). Patients
were randomized 1:1 to a single intratympanic injection of OTO-313
(0.32 mg) or placebo and are being followed for 4 months. The
primary endpoint is the same as reported for the successful Phase
1/2 trial: a responder analysis based on the proportion of patients
who report a clinically meaningful improvement in the Tinnitus
Functional Index (TFI) from baseline to Months 1 and 2 following
treatment. Top-line results for all timepoints are expected to be
available in mid-2022.
"We are excited to fully enroll this trial ahead of schedule,
which we believe is an indication of the strong unmet medical need
in the treatment of tinnitus,” said David A. Weber, Ph.D.,
president and CEO of Otonomy. “Tinnitus 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. Unfortunately, there are no approved drug treatments
for tinnitus and current therapy focuses on coping and masking
mechanisms. We thank the patients and investigators who enabled us
to achieve this important milestone for the OTO-313 program.”
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 NMDA receptor antagonist gacyclidine. Otonomy believes
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. 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. A Phase 1/2 trial of OTO-313 in
patients with unilateral tinnitus of at least moderate severity
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. In addition to the ongoing
Phase 2 trial, Otonomy is initiating a 1-month safety study for
bilateral and higher (0.64 mg) dosing of OTO-313 with results
expected in the second half of 2022. Together, these clinical data
are expected to support an End-of-Phase 2 meeting with the FDA and
inform the design of the OTO-313 Phase 3 clinical program planned
to start in the first half of 2023.
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 regarding the development plans and
timelines for OTO-313; the potential benefits of OTO-313;
anticipated timing of top-line results of the Phase 2 clinical
trial and 1 month safety study of OTO-313, and the expectations
regarding such clinical data; the anticipated timing of the start
of the OTO-313 Phase 3 program; 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 responses to the
pandemic, including current and future impacts to Otonomy’s
operations, the initiation and progression of, and enrollment in,
its planned and current clinical trials, and patient conduct and
compliance; Otonomy’s ability to accurately forecast financial
results; Otonomy’s 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, 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 any promotional, collaboration 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; Otonomy’s ability to obtain regulatory approval
and 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, 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 November 10, 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 ScienceCate CullenAccount
Director205.910.4443ccullen@spectrumscience.com
Investor InquiriesICR WestwickeRobert H. UhlManaging
Director858.356.5932robert.uhl@westwicke.com
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