Otonomy Provides Update on OTIVIDEX® Program
July 06 2020 - 4:02PM
Otonomy, Inc. (Nasdaq: OTIC), a biopharmaceutical company
dedicated to the development of innovative therapeutics for
neurotology, today provided an update on the statistical analysis
plan related to the ongoing Phase 3 clinical trial of OTIVIDEX in
Ménière’s disease. In response to questions received from the U.S.
Food and Drug Administration (FDA) regarding use of the Generalized
Poisson model to analyze the daily vertigo count data reported by
patients, Otonomy submitted a revised statistical analysis plan
that uses a statistical test called the Negative Binomial model for
the primary analysis of the ongoing trial.
Otonomy selected the Negative Binomial model to address the
FDA’s questions because it believes it provides the best fit of the
OTIVIDEX clinical data based on the Phase 2b trial (for patients
with vertigo enrollment criteria matching the Phase 3 clinical
trials), the AVERTS-2 Phase 3 clinical trial, and the integrated
dataset from both trials. As the table below indicates, the ad hoc
analysis of the Definitive Vertigo Day (DVD) count data reported by
patients for Month 3 is statistically significant (p value <
0.05) using the Negative Binomial model for each of these prior
trial populations as well as the integrated summary.
p value for Analysis of DVD Count in Month
3 |
Phase 2b* (n = 97) |
AVERTS-2**(n = 111) |
Integrated Dataset |
Generalized Poisson Model |
0.002 |
0.013 |
< 0.001 |
Negative Binomial Model |
0.016 |
0.008 |
< 0.001 |
*Patients with baseline DVD count of 4-22 days during the
one-month baseline period**Patients who completed 3-month follow-up
period (of which 105 completed daily diaries)
“We have recently completed an extensive review of the
statistical analysis model that we believe best fits the OTIVIDEX
clinical data, which is characterized by approximately 40% of
OTIVIDEX-treated patients having no DVD’s in Month 3,” said David
A. Weber, Ph.D., president and CEO of Otonomy. “Based on this
review, we determined that the Negative Binomial model provides an
improved fit and reduced Type 1 error compared to the Generalized
Poisson model. The Negative Binomial model also gives us additional
power to detect a treatment benefit enabling us to comfortably
reduce the target patient enrollment in the ongoing trial from 160
to 142 patients while maintaining more than 90% power. We look
forward to completing the enrollment of this trial during the third
quarter of 2020 and announcing results in the first quarter of
2021.”
Webcast and Conference Call
Otonomy management will review this update for the OTIVIDEX
program together with a review of the OTO-313 Phase 1/2 trial
results (announced under a separate release) during a webcast and
conference call 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 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 and announcement of results, patient
recruitment and enrollment and activity for, conduct of, the
ongoing Phase 3 clinical trial of OTIVIDEX in Ménière’s disease;
statements relating to updated statistical analysis plan related to
the ongoing Phase 3 clinical trial of OTIVIDEX; expectations
regarding the Negative Binomial model; 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 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; Otonomy’s dependence on third parties
to conduct nonclinical studies and clinical trials; expectations
regarding potential therapy benefits; 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
Otonomy (NASDAQ:OTIC)
Historical Stock Chart
From Jun 2024 to Jul 2024
Otonomy (NASDAQ:OTIC)
Historical Stock Chart
From Jul 2023 to Jul 2024