Otonomy Provides Update on OTIVIDEX® and OTO-313 Programs
November 30 2020 - 7:30AM
Otonomy, Inc. (Nasdaq: OTIC), a biopharmaceutical company
dedicated to the development of innovative therapeutics for
neurotology, today provided updates regarding the statistical
analysis plan for the ongoing Phase 3 trial of OTIVIDEX in
Ménière’s disease, and outlined plans for a Phase 2 trial of
OTO-313 in tinnitus.
- OTIVIDEX: FDA’s
review of the OTIVIDEX statistical analysis
plan confirms use of the Negative
Binomial model for analysis of the primary endpoint in the
ongoing Phase 3 clinical
trial in
Ménière’s
disease. In July
2020, Otonomy submitted a revised statistical analysis plan for the
ongoing trial to the U.S. Food and Drug Administration (FDA) that
proposed use of the Negative Binomial model for primary analysis of
the daily vertigo count data reported by patients. Otonomy believes
that this statistical test provides the best fit of the OTIVIDEX
clinical data based on the Phase 2b trial, the AVERTS-2 Phase 3
trial, and the integrated dataset from both trials. As previously
reported, the ongoing Phase 3 clinical trial has completed
enrollment and results are expected in the first quarter of 2021.
Assuming positive results, submission of a New Drug Application to
the FDA is planned for the third quarter of 2021.
- OTO-313: Phase 2
trial design to be
based on the successful
Phase 1/2 trial,
and initiation is expected
in the first quarter of 2021. In
July 2020, Otonomy reported positive top-line 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 a single intratympanic injection of OTO-313
using the Tinnitus Functional Index (TFI) that was correlated with
tinnitus loudness, tinnitus annoyance and patient global impression
of change measures. Based on continued analysis of this data, input
from key opinion leaders, and feedback from the FDA in a Type C
meeting, Otonomy intends to evaluate the same dose for OTO-313 in a
Phase 2 trial that will enroll an enriched unilateral tinnitus
patient population. To enrich the study population, Otonomy intends
to exclude patients with severe hearing loss and increase the
minimum TFI score required for entry. The company will also expand
the unilateral patient population eligible for enrollment by
increasing the time from tinnitus onset, and will extend the
observation period to assess durability of the treatment
effect.
“We appreciate the timely feedback from the FDA that supports
our plan to analyze the OTIVIDEX Phase 3 trial results and,
together with input from tinnitus clinical experts, will help us
finalize the OTO-313 Phase 2 trial design,” said David A. Weber,
Ph.D., president and CEO of Otonomy. “We are looking forward to
having the OTIVIDEX results and initiating the OTO-313 Phase 2
trial in the first quarter of 2021. In the meantime, we are working
to complete the OTO-413 Phase 1/2 trial in patients with
speech-in-noise hearing deficit, and expect to announce results in
December.”
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 relating to the design of (including
without limitation regarding dose and patient population),
initiation of, development activity for, and advancement of
clinical trials; statements relating to the timing of results,
activity for, and conduct of ongoing clinical trials; statements
relating to the updated statistical analysis plan for the ongoing
Phase 3 clinical trial of OTIVIDEX and expectations regarding the
Negative Binomial model; statements regarding plans to submit
a New Drug Application for OTIVIDEX; 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 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 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 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 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 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; Otonomy’s ability to manage operating expenses; 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 November 4, 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
President404.865.3601cramsey@spectrumscience.com
Investor InquiriesWestwicke ICRRobert H. UhlManaging
Director858.356.5932robert.uhl@westwicke.com
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