Otonomy Announces OTIVIDEX™ Data Presentation at American Academy of Otolaryngology - Head and Neck Surgery Foundation Annu...
October 02 2018 - 7:30AM
Otonomy, Inc. (NASDAQ: OTIC), a biopharmaceutical company
dedicated to the development of innovative therapeutics for
otology, today announced that previously reported positive results
from the AVERTS-2 Phase 3 clinical trial of OTIVIDEX in patients
with Ménière’s disease will be presented in a podium presentation
at the annual meeting of the American Academy of Otolaryngology -
Head and Neck Surgery Foundation (AAO-HNSF) to be held in Atlanta
from October 7-10.
John Phillips, FRCS (ORL-HNS), Consultant Otolaryngologist at
Norfolk & Norwich University Hospitals in the United Kingdom,
will present the AVERTS-2 clinical trial results on Tuesday,
October 9 at 1:27 p.m. EDT. The AVERTS-2 trial achieved its primary
endpoint, count of definitive vertigo days (DVD) by Poisson
Regression analysis in Month 3 (p value = 0.029), based on analysis
of all 174 patients enrolled in the trial. This endpoint, as well
as a number of additional efficacy endpoints, were statistically
significant (p value < 0.05) for patients who were enrolled in
the AVERTS-2 trial through Month 3 at the time of study
termination.
"I am pleased to present the results from the AVERTS-2 trial,
which is the first large-scale, randomized, placebo-controlled
clinical trial to demonstrate a statistically significant
improvement of vertigo in Ménière’s disease patients," said Mr.
Phillips. "Furthermore, the treatment benefit experienced by
patients following a single intratympanic administration of
OTIVIDEX was clinically meaningful with the group demonstrating a
6.2 day reduction in the mean reported number of DVD from baseline
to Month 3 and a 2.5 day mean improvement compared to the placebo
group in Month 3."
Otonomy believes that the AVERTS-2 trial will serve as one of
two successful pivotal studies required to support the U.S.
registration of OTIVIDEX in Ménière’s disease, based on a Type C
meeting held with the U.S. Food and Drug Administration (FDA) in
the first quarter of 2018. The second required study was initiated
in July 2018 with top-line results expected in the first half of
2020. The design and conduct of this additional trial is based on
the AVERTS-2 trial including the same primary efficacy endpoint,
daily diary vertigo scale, use of a one-month lead-in period, and
primary analysis at three months after a single treatment.
“The positive AVERTS-2 trial results and the consistency
of those results to the Phase 1b and 2b studies provide robust
support for the current trial,” said Anthony A. Mikulec, M.D., MBA,
Professor, Chief of Otology and Neurotology, Saint Louis University
School of Medicine. “The company has also learned important lessons
from the AVERTS-1 trial regarding the need to manage patient
expectation bias in order to control the placebo response. One way
this is being addressed is through careful attention to patient
communication, a change that has been well-received by
investigators and clinical study staff in the ongoing Phase 3
trial."
About Otonomy
Otonomy is a biopharmaceutical company dedicated to the
development of innovative therapeutics for otology. 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, timing of top-line results and expectations for the
Phase 3 trial for OTIVIDEX and the Company’s belief that the
AVERTS-2 trial will serve as one of the two successful pivotal
studies required to support the U.S. registration of OTIVIDEX in
Ménière’s disease. 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: Otonomy’s limited operating history and its 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 in clinical trials;
Otonomy’s ability to obtain regulatory approval for its product
candidates; 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;
Otonomy’s dependence on third parties for the manufacture of its
product candidates; Otonomy’s dependence on a small number of
suppliers for raw materials; Otonomy’s ability to protect its
intellectual property related to its product candidates in the
United States and throughout the world; expectations regarding
potential 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; 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 August 8, 2018,
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:
Investor InquiriesWestwicke PartnersRobert H. UhlManaging
Director858.356.5932robert.uhl@westwicke.com
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