Otonomy Reports Positive Top-Line Results from Phase 1/2 Clinical Trial of OTO-313 in Patients with Tinnitus
July 06 2020 - 4:04PM
Otonomy, Inc. (Nasdaq: OTIC), a biopharmaceutical company
dedicated to the development of innovative therapeutics for
neurotology, today announced positive top-line results from the
Phase 1/2 clinical trial of OTO-313 in patients with persistent
tinnitus of at least moderate severity. The exploratory efficacy
cohort of the trial included 31 evaluable patients randomized to a
single intratympanic injection of OTO-313 or placebo (1:1
randomization) and then followed for eight weeks. Patients reported
the severity of their tinnitus symptoms using the Tinnitus
Functional Index (TFI), a clinically-validated instrument, and by
the daily reporting of their tinnitus loudness and annoyance. The
trial achieved its objectives by demonstrating a positive clinical
signal for OTO-313 based on a TFI responder analysis, with a
favorable safety profile. Given these results, Otonomy intends to
advance OTO-313 into full Phase 2 development which may include
evaluation of a higher dose and/or retreatment with OTO-313.
Top-line results for the Phase 1/2 trial were as follows:
- 43% of OTO-313 patients were responders at both Day 29 and Day
57 compared to 13% of placebo patients. A responder is a patient
whose TFI score decreases by 13-points or more from their baseline
score, a change considered clinically meaningful based on the TFI
instrument validation.
- For patients who were responders at both Day 29 and Day 57,
OTO-313 demonstrated a higher responder rate than placebo at all
TFI improvement levels considered clinically meaningful (TFI
reduction ≥ 13, 15, 20, 25, and 30 points). The difference in
responder rate between OTO-313 and placebo was statistically
significant on post hoc analysis (p-value < 0.05) for TFI
reductions ≥ 13, 15, and 20 points.
- OTO-313 patients who were responders at both Day 29 and Day 57
reported improvements in both tinnitus loudness and annoyance
levels based on daily diaries and also reported improvement in the
Patient Global Impression of Change (PGIC), a general assessment of
tinnitus status. There was a very strong relationship demonstrated
between the improvement in TFI score reported by these OTO-313
responders and their improvement in tinnitus loudness and annoyance
levels as well as PGIC based on the calculated correlation
coefficients of ≥ 0.8 for these endpoints.
- A single intratympanic injection of OTO-313 was well-tolerated
with lower incidence of adverse events than the placebo group.
“We are excited to announce these positive clinical results for
OTO-313 and to advance this potential treatment for patients
suffering from the high burden of persistent tinnitus,” said David
A. Weber, Ph.D., president and CEO of Otonomy. “This is also a
great start to our three planned clinical trial readouts with
results for our OTO-413 Phase 1/2 trial expected in the fourth
quarter of 2020 and results from the Phase 3 trial of OTIVIDEX® in
Ménière’s disease expected in the first quarter of 2021.”
"Tinnitus is a common problem that affects millions of people
around the world. A significant proportion of patients experience
moderate to severe tinnitus, which can negatively impact sleep and
relaxation, disrupt the ability to focus at work and at home,
create feelings of distress and anxiety, and lower overall quality
of life,” said Kenneth Maxwell, M.D., a Neurotologist at Piedmont
Ear Nose & Throat Associates in Winston-Salem, North Carolina
and an investigator in the OTO-313 Phase 1/2 trial. “Unfortunately,
there are no FDA approved drug treatments for tinnitus and existing
approaches rely on coping strategies. Therefore, I am very
encouraged by the treatment response observed with OTO-313 in this
trial as well as the consistency of the improvement for OTO-313
responders across all four tinnitus endpoints examined in this
trial, and I look forward to participating in future clinical
studies.”
Webcast and Conference Call
Otonomy management will host a webcast and conference call
regarding these program updates at 4:30 p.m. ET / 1:30 p.m. PT
today. The live call may be accessed by dialing (877) 305-6769 for
domestic callers and (678) 562-4239 for international callers with
conference ID code number: 4273643. A live webcast of the call will
be available online in the investor relations section of Otonomy’s
website at www.otonomy.com and will be archived there for 30
days.
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 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 providing localized drug administration to the inner
ear. 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. The therapeutic potential of gacyclidine for
tinnitus has been demonstrated in preclinical models and several
pilot clinical studies. OTO-313 utilizes a novel, patent-protected
formulation technology to provide several weeks of gacyclidine drug
exposure in the inner ear compartment following a single
intratympanic injection.
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, expectations regarding the potential benefits,
development activity and advancement of clinical trials; statements
relating to the timing of results, patient recruitment and activity
for, conduct of, ongoing clinical trials; statements relating to
potential treatment for patients suffering from the high burden of
persistent tinnitus; statements by an investigator in the OTO-313
Phase 1/2; statements by Otonomy’s president and CEO; and estimated
costs of tinnitus. 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 manufacturing of its product candidates, the
progression of its current clinical trials, enrollment in its
current and future clinical trials and patient conduct and
compliance; 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; the
integrity of patient-reported outcomes in its current and future
clinical trials; 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; Otonomy’s ability to
protect its intellectual property 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; 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 (the "SEC") on May 7, 2020, 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
President404.865.3601 cramsey@spectrumscience.com
Investor InquiriesWestwicke ICRRobert H. UhlManaging
Director858.356.5932robert.uhl@westwicke.com
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