Otonomy Receives FDA Clearance of Investigational New Drug Application for Tinnitus Product Candidate, OTO-311
October 05 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 that the FDA has cleared the company's
Investigational New Drug application (IND) for tinnitus product
candidate OTO-311, a sustained-exposure formulation of the
N-Methyl-D-Aspartate (NMDA) receptor antagonist, gacyclidine. The
IND clearance enables Otonomy to initiate a Phase 1 dose escalation
clinical safety trial of OTO-311 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.
Tinnitus is the medical term for hearing noise when there is no
outside source of the sound. It is often described as a ringing in
the ear but can also sound like roaring, clicking, hissing or
buzzing. Tinnitus sufferers may have trouble hearing,
concentrating, working and sleeping.
"Despite the debilitating nature of tinnitus that impacts
millions of Americans, including a high proportion of military
veterans, there is no cure and there are no FDA-approved drug
treatments," said David A. Weber, Ph.D., president and chief
executive officer of Otonomy. "Initiating this Phase 1 trial for
OTO-311 before the end of 2015 meets our commitment to investors
and also serves as an important first step towards our goal of
bringing a single-dose intratympanic treatment to tinnitus
sufferers."
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. AuriPro™ 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 in development as a
treatment for 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 Otonomy's future financial or operating performance.
Forward-looking statements in this press release include, but are
not limited to, the initiation, timing and design of Otonomy's
Phase 1 clinical trial with OTO-311, the initiation, timing and
design of Otonomy's Phase 3 clinical trials with OTO-104 and the
timing of the launch of AuriPro™. 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: 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; developments related
to competitors and the 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; and other risks. Otonomy undertakes no
obligation to update any forward-looking statements, whether as a
result of new information, future events or otherwise, except as
required by applicable 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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