Otonomy Initiates Patient Enrollment in Single Phase 3 Clinical Trial of OTIPRIO™ in Patients with Acute Otitis Externa
June 09 2016 - 7:30AM
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 patient in the single OTIPRIOTM Phase 3
clinical trial in pediatric and adult patients with acute otitis
externa (AOE), also known as swimmer’s ear. The company expects to
complete this trial and report topline results in the fourth
quarter of 2016. If the results are positive, Otonomy expects to
submit a supplemental New Drug Application (sNDA) to the U.S. Food
and Drug Administration (FDA) in the first half of 2017.
“Initiation of this Phase 3 clinical trial keeps us on track to
recruit patients during the peak summer season for AOE which is
important in order to complete enrollment and report topline
results by end of the year,” said David A. Weber, Ph.D., president
and CEO of Otonomy. “This label expansion indication is significant
for OTIPRIO for several reasons. First, AOE would be the first
OTIPRIO indication that is predominantly physician office-based.
Second, this would expand OTIPRIO usage to the adult population
since AOE affects patients of all ages. And third, this provides an
opportunity for use of OTIPRIO by pediatricians and primary care
physicians who currently treat the majority of AOE patients. We
look forward to successfully completing this trial and filing for
FDA approval to support the market expansion of OTIPRIO in the
United States.”
The one-month, prospective, randomized, double-blind,
sham-controlled, multicenter, Phase 3 clinical trial is expected to
enroll approximately 500 patients age 6 months and older with acute
otitis externa, in the United States and Canada. Patients are
randomized to receive a single administration of 12 mg OTIPRIO
(equal to 0.2 mL) or sham (empty syringe) to the external ear canal
of the affected ear(s). The primary endpoint is clinical cure at
Day 8 defined as complete resolution of the signs and symptoms
related to acute otitis externa (i.e. tenderness, erythema, and
edema) as determined by a blinded clinical assessor. Safety outcome
measures will include reporting of adverse events and otoscopic
examinations. Additional information about the clinical trial can
be found at www.clinicaltrials.gov.
About Acute Otitis Externa
Acute otitis externa (AOE), also known as swimmer’s ear, is a
common condition involving infection and inflammation of the
external ear canal typically caused by bacterial infection.
According to medical claims data, there are nearly 4 million
episodes of AOE each year in the United States. Symptoms usually
appear within a few days of swimming and include itchiness,
redness, swelling, pain and pus draining from the infected ear.
Antibiotic ear drops are considered the standard of care treatment
for AOE with the typical regimen requiring several administrations
to the affected ear each day for up to 10 days.
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. Two Phase 3 trials in
Ménière's disease patients are underway, with results expected
during the second half of 2017. 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, the design and timing of results for the OTIPRIO
Phase 3 clinical trial in acute otitis externa, the timing of the
sNDA filing for OTIPRIO in acute otitis externa, and the timing of
results for the two OTO-104 Phase 3 clinical trials in Ménière's
disease. 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-104 and
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; the impact of coverage and
reimbursement decisions by third-party payors on the pricing and
market acceptance of OTIPRIO; 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 Quarterly
Report on Form 10-Q filed with the Securities and Exchange
Commission (the "SEC") on May 9, 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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