Otonomy Announces Top-Line Results for the Phase 3 Clinical Trial of OTIVIDEX® in Patients with Ménière's Disease
February 22 2021 - 7:00AM
Otonomy, Inc. (Nasdaq: OTIC), a biopharmaceutical company
dedicated to the development of innovative therapeutics for
neurotology, today announced that the Phase 3 clinical trial of
OTIVIDEX in patients with Ménière’s disease did not achieve the
primary endpoint, which was the count of definitive vertigo days
(DVD) in Month 3 for OTIVIDEX vs. placebo for the intent-to-treat
(ITT) population (n = 148; p value = 0.312) using the Negative
Binomial Model. This analysis did achieve statistical significance
for the per protocol (PP) population (n = 136; p value = 0.031).
These results were similar using the Generalized Poisson model (p
value = 0.340 for ITT and p value = 0.030 for PP).
“We are disappointed by the top-line results for
the primary intent-to-treat population and are undertaking an
assessment to understand the difference observed with the per
protocol analysis. We thank the many patients, clinical
investigators and study site staff who supported this effort,” said
David A. Weber, Ph.D., president and CEO of Otonomy. “Our focus
turns to the strong pipeline we have built as recently highlighted
by the successful clinical trial results for OTO-313 in tinnitus
and OTO-413 in hearing loss. OTO-313 and OTO-413 each address a
large patient population with significant unmet need and no
approved drug therapy. These programs provide an attractive
opportunity for the company with clinical readouts anticipated in
mid-2022. We expect that our existing cash balance will permit us
to achieve these clinical readouts as well as advance our
preclinical hearing loss programs including OTO-825, a gene therapy
for congenital hearing loss."
The company previously reported a cash balance
including cash, cash equivalents, and short-term investments
totaling $86.3 million as of December 31, 2020, GAAP operating
expenses for full year 2020 of $42.6 million and non-GAAP operating
expenses, which exclude stock-based compensation, for full year
2020 of $36.5 million.
About OTIVIDEX Phase 3 Trial
The OTIVIDEX Phase 3 trial was a four month,
prospective, randomized, double-blind, placebo-controlled trial of
patients with unilateral Ménière’s disease conducted in the United
States and Europe. Following an initial one month lead-in period,
eligible subjects were randomized 1:1 to a single intratympanic
injection of OTIVIDEX or placebo and then followed for three
months. A total of 149 patients were randomized into the study. The
primary endpoint was the count of definitive vertigo days in Month
3 for OTIVIDEX vs. placebo assessed using the Negative Binomial
model.
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 related to plans and
expectations regarding OTO-313, OTO-413 and OTO-825, and Otonomy’s
other preclinical programs, including with respect to patient
populations; anticipated timing of clinical readouts for OTO-313
and OTO-413; Otonomy’s expectation that its existing cash balance
will permit the company to achieve such clinical readouts as well
as advance its preclinical hearing loss programs; expectations
regarding Otonomy’s ability to advance its pipeline; 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 ability to obtain additional financing; risks
and uncertainties related to the impact of this announcement on the
Company’s business, financial condition and the price of the
Company’s securities; 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 Otonomy’s collaboration,
co-promotion 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; 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 Annual Report on Form 10-K filed with
the Securities and Exchange Commission (SEC) on February 11, 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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