Otonomy Announces Publication of Phase 1/2 Trial Results Showing Tinnitus Improvement in Patients Receiving OTO-313
October 12 2021 - 7:30AM
Otonomy, Inc. (Nasdaq: OTIC), a biopharmaceutical company
dedicated to the development of innovative therapeutics for
neurotology, today announced the publication of its OTO-313 Phase
1/2 clinical trial results in Otology & Neurotology, a leading
peer-reviewed journal in otolaryngology. These are the first
published results to demonstrate a reduction in tinnitus severity
for a drug treatment compared to placebo using the Tinnitus
Functional Index (TFI), a clinically-validated instrument.
“Publication of these positive clinical results is an important
milestone for the millions of people suffering from tinnitus, which
can negatively impact sleep and relaxation, disrupt life at work
and home, and create feelings of distress and anxiety,” said David
Baguley, Professor of Hearing Sciences at the University of
Nottingham, former Head of Audiology at Cambridge University
Hospitals NHS Foundation Trust, and an internationally recognized
tinnitus expert who is a co-author on the publication. “This is
also an encouraging moment for clinicians who currently lack any
drug therapy to reduce the severity of tinnitus that patients
experience. I am particularly pleased to see the good concurrence
between TFI and the other endpoint measures at multiple timepoints
for responders in this trial, which demonstrates a robust treatment
benefit.”
"Availability of the Phase 1/2 trial results is constructive for
our efforts to maintain the favorable pace of patient enrollment in
the ongoing Phase 2 trial that is on-track with our anticipated
timing for results in mid-2022,” said David A. Weber, Ph.D.,
president and CEO of Otonomy.
The exploratory efficacy cohort of the Phase 1/2 trial included
31 evaluable patients with persistent unilateral tinnitus of at
least moderate severity based on the TFI. Patients were randomized
to a single intratympanic injection of OTO-313 or placebo (1:1
randomization) and then followed for 8 weeks. In the trial, 43% of
OTO-313 patients reported a clinically meaningful improvement on
the TFI at both Week 4 and Week 8 compared to 13% of placebo
patients (ad hoc p-value < 0.05). Furthermore, OTO-313 patients
who were TFI responders also reported improvements in tinnitus
loudness and annoyance levels, and improvement in the Patient
Global Impression of Change.
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. A Phase 2 trial is currently underway with
results expected in mid-2022.
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, expectations regarding the potential benefits,
development activity and advancement of the OTO-313 program;
statements related to plans and expectations regarding OTO-313,
including with respect to patient recruitment and activity for the
ongoing OTO-313 Phase 2 clinical trial; anticipated timing of
topline results of the Phase 2 clinical trial of OTO-313;
statements relating to potential treatment for patients suffering
from the high burden of persistent tinnitus; statements by a
co-author of the OTO-313 Phase 1/2 publication; 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 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 August 4, 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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