Otonomy Initiates Phase 1/2 Clinical Trial of OTO-313 in Tinnitus
April 11 2019 - 7:30AM
Otonomy, Inc. (NASDAQ: OTIC), a biopharmaceutical company
dedicated to the development of innovative therapeutics for
neurotology, today announced the initiation of a Phase 1/2 clinical
trial of OTO-313, a sustained-exposure formulation of the NMDA
receptor antagonist gacyclidine, in patients with tinnitus. The
randomized, double-blind, placebo-controlled Phase 1/2 study will
include an initial safety cohort followed by an exploratory
efficacy study that will enroll approximately 50 patients with
subjective tinnitus.
"Tinnitus is a common problem affecting millions of people,”
said Susan Marenda King, M.D., Neurotologist and Otologist at the
Ear Medical Group in San Antonio, and Clinical Professor at the
University of Texas Health Science Center. “The constant annoyance
of tinnitus can negatively impact a patient's quality of life by
disrupting their ability to concentrate, enjoy leisure activities
and obtain restful sleep. Unfortunately, we currently have no drug
therapy to offer these patients. I am excited about the potential
of OTO-313 and pleased to be part of the Phase 1/2 clinical
trial.”
"We are excited to advance the clinical development of OTO-313
by initiating this trial, which will evaluate the therapeutic
potential of OTO-313 in patients with tinnitus,” said David A.
Weber, Ph.D., president and CEO of Otonomy. “We expect results from
this study in the first half of 2020 and will use the information
to inform the design and plan for further clinical
development.”
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.
Approximately 10 percent of U.S. adults live with the condition,
which can severely impact daily activities and often leads to
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 NMDA receptor antagonist gacyclidine in development for
the treatment of tinnitus. A Phase 1 clinical safety trial was
previously completed for an initial formulation of gacyclidine,
with no safety concerns observed. OTO-313 is an improved
formulation of gacyclidine to be administered via 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, timing of results, patient recruitment and
enrollment plans, and trial design and conduct for the Phase 1/2
clinical trial for OTO-313, 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:
Otonomy’s limited operating history and its expectation that it
will incur significant losses for the foreseeable future; 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; Otonomy’s ability to obtain
regulatory approval for its product candidates; the risks of the
occurrence of any event, change or other circumstance that could
give rise to the termination of the co-promotion agreement between
Otonomy and Mission; 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;
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-K filed with the
Securities and Exchange Commission (the "SEC") on March 4, 2019,
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 ScienceLeticia DiazVice President
202.587.2517ldiaz@spectrumscience.com
Investor InquiriesWestwicke PartnersRobert H. UhlManaging
Director858.356.5932robert.uhl@westwicke.com
Otonomy (NASDAQ:OTIC)
Historical Stock Chart
From May 2024 to Jun 2024
Otonomy (NASDAQ:OTIC)
Historical Stock Chart
From Jun 2023 to Jun 2024