Otonomy Initiates Phase 1 Clinical Trial for Tinnitus Product Candidate, OTO-311
November 16 2015 - 7:30AM
Otonomy, Inc. (Nasdaq:OTIC), a clinical-stage biopharmaceutical
company focused on the development and commercialization of
innovative therapeutics for diseases and disorders of the ear,
today announced the enrollment of the first subjects in a Phase 1
clinical safety trial of OTO-311, a product candidate for the
treatment of tinnitus. OTO-311 is a sustained-exposure formulation
of the potent and selective N-Methyl-D-Aspartate (NMDA) receptor
antagonist gacyclidine. This Phase 1 dose escalation clinical
safety study is being conducted in normal healthy volunteers.
OTO-311 will be given as a single unilateral intratympanic
injection and subjects will be observed for four weeks following
dosing.
"We are pleased to initiate the clinical development of OTO-311
for tinnitus with the dosing of the first subjects in our Phase 1
clinical safety trial," said David A. Weber, Ph.D., president and
CEO of Otonomy. "We expect to complete this trial in the first half
of 2016, and initiate a Phase 2 trial in tinnitus patients during
the second half of the year. We believe that a single-dose
intratympanic treatment will be of interest to patients and their
physicians."
About Tinnitus
The American Tinnitus Association reports that approximately 16
million patients in the United States have tinnitus symptoms severe
enough to seek medical attention, and about two million patients
cannot function on a normal day-to-day basis. Furthermore, the
United States Department of Defense reports that tinnitus accounts
for the most prevalent service-connected disability among veterans
and that the costs of service-related tinnitus are estimated to
exceed $2 billion. While the most common cause of tinnitus is
exposure to loud noise, a number of other factors can be involved
including heart or blood vessel problems, hormonal changes in
women, ear and sinus infections, certain medications and thyroid
problems. People with severe tinnitus may have trouble hearing,
working and sleeping. At this time, there is no cure for tinnitus
and there are no FDA-approved drugs for treating this debilitating
condition.
About OTO-311
OTO-311 is a sustained-exposure formulation of the potent and
selective N-Methyl-D-Aspartate (NMDA) receptor antagonist
gacyclidine. Clinical studies, including pilot studies conducted
with gacyclidine, support the use of NMDA receptor antagonists as
potential treatments for tinnitus. In 2013, Otonomy acquired
certain assets and rights to intellectual property related to the
use of gacyclidine for the treatment of tinnitus from an affiliate
of NeuroSystec Corporation, a company founded by serial
entrepreneur Alfred Mann. In 2014, Otonomy entered into an
exclusive license agreement with Ipsen (Euronext:IPN) (ADR:IPSEY)
that enables Otonomy to utilize Ipsen's clinical and non-clinical
gacyclidine data to support worldwide development and regulatory
filings for OTO-311. The clinical data are from several Phase 1 and
Phase 2 trials conducted by Ipsen in more than 300 patients who
received treatment with systemic gacyclidine as a potential
neuroprotectant in various neurologic trauma indications. OTO-311
utilizes Otonomy's proprietary drug delivery technology to achieve
sustained exposure of gacyclidine in the inner ear from a single
intratympanic (IT) injection.
About Otonomy
Otonomy is a clinical-stage biopharmaceutical company focused on
the development and commercialization of innovative therapeutics
for diseases and disorders of the ear. Otonomy's proprietary
technology provides sustained exposure of drugs to the ear
following a single administration. Otonomy has three product
candidates in development. OTIPRIO™ is an antibiotic that has
completed Phase 3 clinical trials in pediatric patients with middle
ear effusion at the time of tympanostomy tube placement surgery,
and the FDA has assigned a PDUFA action date of December 25, 2015
for the company's New Drug Application. OTO-104 is a steroid that
has completed a Phase 2b clinical trial in 154 patients with
Ménière's disease. Based on these results, Otonomy intends to
initiate two parallel Phase 3 trials for OTO-104 in Ménière's
disease patients with at least one trial initiated by the end of
2015. OTO-311 is an NMDA receptor antagonist for the treatment of
tinnitus that is in a Phase 1 clinical safety trial. 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 Otonomy's future financial or operating performance.
Forward-looking statements in this press release include, but are
not limited to, Otonomy's expectations regarding the commercial
launch of OTIPRIO in the United States, the initiation of two Phase
3 trials for OTO-104, the completion of a Phase 1 clinical trial
for OTO-311 and the initiation of a Phase 2 clinical trial for
OTO-311. 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 substantial additional financing; Otonomy's
dependence on the regulatory and commercial success of OTIPRIO and
OTO-104 and advancing additional product candidates, such as
OTO-311; 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 preclinical and clinical results for its
product candidates, which may not support further development of
product candidates, 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; competition in the
biopharmaceutical industry; Otonomy's dependence on third parties
to conduct preclinical studies and clinical trials; Otonomy's
dependence on third parties for the manufacture of products;
Otonomy's dependence on a small number of suppliers for raw
materials; Otonomy's ability to protect its intellectual property
related to 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 November 10, 2015, 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.
CONTACT: Media Inquiries
Canale Communications
Heidi Chokeir, Ph.D.
Senior Vice President
619.849.5377
heidi@canalecomm.com
Investor Inquiries
Westwicke Partners
Robert H. Uhl
Managing Director
858.356.5932
robert.uhl@westwicke.com
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