Otonomy Initiates Phase 2 Clinical Trial of OTIPRIO™ in Pediatric Patients With Acute Otitis Media With Tympanostomy Tubes
March 09 2016 - 7:46PM
Otonomy, Inc. (NASDAQ:OTIC), a 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 patients in a Phase 2
clinical trial evaluating a single administration of OTIPRIO™
(ciprofloxacin otic suspension) for the treatment of pediatric
patients with acute otitis media with tympanostomy tubes (AOMT).
Otonomy previously completed a Phase 2 trial that successfully
demonstrated the feasibility of administering OTIPRIO to pediatric
patients with AOMT in an office setting. This second Phase 2 trial
is designed to determine the most appropriate OTIPRIO dose for
further development in this indication.
“Initiation of this Phase 2 clinical trial in AOMT demonstrates
our commitment to actively pursue the registration of OTIPRIO for
expanded indications,” said David A. Weber, Ph.D., president and
CEO of Otonomy. “We believe that AOMT and acute otitis externa will
more than double the U.S. market opportunity for OTIPRIO if
approved for these indications. Furthermore, OTIPRIO’s single-dose,
physician-administered profile is distinct from the current
standard of care which requires multi-dose, multi-day
administration of ear drops.”
The one-month, prospective, multicenter, randomized,
sham-controlled, blinded Phase 2 clinical trial will enroll
approximately 125 pediatric patients in the United States with
unilateral or bilateral AOMT. The trial is designed to evaluate the
safety, tolerability, and comparative clinical activity of two dose
levels of OTIPRIO when administered as a single treatment in the
physician’s office.
About OTIPRIO
OTIPRIO (ciprofloxacin otic suspension) is a fluoroquinolone
antibacterial indicated for the treatment of pediatric patients
with bilateral otitis media with effusion undergoing tympanostomy
tube placement. OTIPRIO is administered by a physician as a single
0.1 mL (6 mg) intratympanic administration into each affected ear,
following suctioning of the middle ear effusion. The
thermosensitive suspension exists as a liquid at or below room
temperature and gels when warmed. In two Phase 3 trials, a single
intraoperative administration of OTIPRIO demonstrated a
statistically significant reduction in the cumulative proportion of
study treatment failures compared to tubes alone (p-value
<0.001).
Important Safety Information for OTIPRIO
Contraindications: OTIPRIO is contraindicated
in patients with a history of hypersensitivity to ciprofloxacin, to
other quinolones, or to any of the components of OTIPRIO.
Warnings and Precautions - Potential
for Microbial Overgrowth: OTIPRIO may result in overgrowth
of nonsusceptible bacteria and fungi. If such infections occur,
institute alternative therapy.
Adverse Reactions: Adverse reactions (incidence
at least 3%) that occurred in two Phase 3 trials with OTIPRIO vs
sham were: nasopharyngitis (5% vs 4%), irritability (5% vs 3%), and
rhinorrhea (3% vs 2%).
Use in Specific Populations - Pediatric Use:
The safety and effectiveness of OTIPRIO in infants below six months
of age have not been established.
Full prescribing information can be found at www.OTIPRIO.com
About Otonomy
Otonomy is a biopharmaceutical company focused on the
development and commercialization of innovative therapeutics for
diseases and disorders of the ear. OTIPRIO (ciprofloxacin otic
suspension) is approved in the United States for use
during tympanostomy tube placement surgery in pediatric patients
and commercial launch commenced in March 2016. OTO-104 is a steroid
in development for the treatment of Ménière's disease and other
severe balance and hearing disorders. A Phase 3 trial in Ménière's
disease patients is underway in the United States with a
second trial expected to be initiated in the EU during the first
quarter of 2016. OTO-311 is an NMDA receptor antagonist for the
treatment of tinnitus that is in a Phase 1 clinical safety trial.
Otonomy’s proprietary formulation technology utilizes a
thermosensitive gel and drug microparticles to enable single dose
treatment by a physician. 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 future financial or operating performance of Otonomy.
Forward-looking statements in this press release include, but are
not limited to, Otonomy's expectations regarding the timing of the
OTO-104 Phase 3 clinical trial for Ménière's disease in the EU.
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 commercial
success of OTIPRIO and the regulatory success and advancement of
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, 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 OTIPRIO and
product candidates; Otonomy's dependence on a small number of
suppliers for raw materials; Otonomy's ability to protect its
intellectual property related to OTIPRIO and 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 Current Report on Form 8-K filed with the
Securities and Exchange Commission (the "SEC") on January 5, 2016,
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 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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