Otonomy Successfully Completes Phase 2 Clinical Trial of OTIPRIO® in Pediatric Patients with Acute Otitis Media with Tympano...
04 October 2016 - 10:30PM
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
successful completion of a Phase 2 clinical trial that evaluated a
single administration of OTIPRIO® (ciprofloxacin otic
suspension) for the treatment of pediatric patients with acute
otitis media with tympanostomy tubes (AOMT). The Phase 2 trial was
designed to evaluate the safety and tolerability of two dose levels
of OTIPRIO, 6 mg (0.1 mL) and 12 mg (0.2 mL), administered in
pediatric patients with AOMT and to determine the most appropriate
dose for further development in this indication. The trial
demonstrated that both OTIPRIO doses were well-tolerated, achieved
higher and statistically significant (p<0.05) clinical cure
rates over sham (no treatment), with the highest clinical cure rate
observed in the 12 mg dose group.
Additional results from this trial will be presented at the
Otonomy Investor and Analyst Day on October 7 and will be presented
at an upcoming medical conference.
“This study builds on the prior Phase 2 trial, which established
the feasibility of administering OTIPRIO in an awake child in the
physician office setting, by demonstrating that the preferred dose
for further development in AOMT is 12 mg,” said David A. Weber,
Ph.D., president and CEO of Otonomy. “Furthermore, we believe that
achieving statistical significance in the clinical cure rate versus
sham, with a relatively small number of subjects in this study,
establishes a favorable benchmark for sizing a successful
registration program for OTIPRIO in AOMT. We intend to meet with
the FDA to discuss the requirements for such a program following
our completion of the ongoing Phase 3 registration trial in acute
otitis externa, the first label expansion indication for
OTIPRIO."
The one-month, prospective, randomized, sham-controlled, blinded
Phase 2 clinical trial enrolled 95 pediatric patients with
unilateral or bilateral AOMT at 12 centers in the United States.
The trial was designed to evaluate the safety, tolerability, and
comparative clinical activity of two dose levels of OTIPRIO, 6 mg
(0.1 mL) and 12 mg (0.2 mL), when administered as a single
treatment in the physician’s office. Clinical activity was
primarily assessed at Day 15 based on clinical cure rate defined as
resolution of otorrhea determined by the physician through an
otoscopic examination.
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 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, and
label expansion indications for OTIPRIO; 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 timing and
outcome of hospital pharmacy and therapeutics reviews and other
facility reviews; 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 August 4, 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 InquiriesCanale CommunicationsHeidi Chokeir, Ph.D.Senior
Vice President619.849.5377heidi@canalecomm.com
Investor InquiriesWestwicke PartnersRobert H. UhlManaging
Director858.356.5932robert.uhl@westwicke.com
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