Otonomy Reports Phase 2b Topline Data for OTO-104 in Meniere's Disease
May 21 2015 - 4:05PM
- Narrowly missed primary endpoint of reduction in vertigo
frequency during Month 3 following treatment compared to a one
month baseline period, p = 0.067
- Achieved statistical significance on multiple prospectively
defined secondary endpoints
- Company believes data provide a strong basis to move forward
into two parallel Phase 3 trials
- Management will conduct a webcast and conference call to
discuss the results at 4:30 p.m. EDT today
Otonomy, Inc. (Nasdaq:OTIC), a clinical stage biopharmaceutical
company developing innovative therapeutics for diseases and
disorders of the inner and middle ear, today announced topline
results from its Phase 2b trial evaluating OTO-104 in patients with
unilateral Ménière's disease. The primary endpoint of the trial was
reduction in vertigo frequency during Month 3 following treatment
compared to a one month baseline period. In the topline analysis,
OTO-104 demonstrated a 61% reduction from baseline in vertigo
frequency in Month 3 vs. 43% for placebo with a p value of 0.067,
which narrowly missed achieving statistical significance. In
addition to Month 3, a similar positive trend was also observed
during Month 2 following treatment.
The trial achieved statistical significance (p < 0.05) for
multiple prospectively defined secondary vertigo endpoints at
multiple time points as summarized below.
|
Month
2 |
Month
3 |
Secondary
Endpoint |
OTO-104 |
Placebo |
p value |
OTO-104 |
Placebo |
p value |
Count of definitive vertigo days |
2.16 |
3.11 |
0.035 |
1.64 |
2.54 |
0.030 |
Change in vertigo severity score from
baseline |
-0.39 |
-0.25 |
0.046 |
-0.46 |
-0.32 |
0.046 |
Change in average daily vertigo count
from baseline |
-0.48 |
-0.24 |
0.042 |
-0.53 |
-0.33 |
0.065 |
There was no OTO-104 treatment effect observed for tinnitus
endpoints that were considered exploratory efficacy endpoints of
the trial.
"While the trial narrowly missed achieving statistical
significance on the primary endpoint, we believe the clear efficacy
trends observed along with the multiple secondary endpoints where
statistical significance was achieved provide a solid basis to move
OTO-104 forward into Phase 3 testing," said David A. Weber, Ph.D.,
president and CEO of Otonomy. "We plan to request an End-of-Phase 2
meeting with the FDA and intend to initiate two parallel Phase 3
trials in Ménière's disease with the first beginning by the end of
2015."
OTO-104 was well tolerated in the study and no drug-related
serious adverse events were observed. Persistent perforations of
the tympanic membrane at the end of Month 4 were observed in 2.6%
of patients treated with OTO-104 which is consistent with the
findings from the OTO-104 Phase 1b trial as well as published
results for trials utilizing intratympanic injection of steroid
solutions.
Conference Call and Webcast
Otonomy management will host a webcast and conference call
regarding this announcement at 4:30 p.m. EDT/1:30 p.m. PDT
today. A slide presentation for the call will be available shortly
before the event on Otonomy's website on the "Events and
Presentations" page at
http://investors.otonomy.com/phoenix.zhtml?c=234082&p=irol-calendar. The
live call may be accessed by dialing (877) 305-6769 for domestic
callers and (678) 562-4239 for international callers with
conference ID code number: 53772865. A live webcast and archive of
the call will be available from the investor relations section of
the company website at www.otonomy.com. A telephone replay of the
call will be available by dialing (855) 859-2056 for domestic
callers or (404) 537-3406 for international callers and entering
the conference code number: 53772865.
About the Phase 2b Trial
The trial was designed to assess the safety, tolerability and
efficacy of OTO-104 in patients with unilateral Ménière's disease.
Upon screening, all subjects entered into a one month observational
period for a baseline assessment during which subjects recorded
their vertigo and tinnitus symptoms via a daily diary. Following
the lead-in period, eligible subjects were randomized 1:1 to a
single intratympanic injection of 12 mg OTO-104 or placebo (gel
vehicle). A total of 154 patients were randomized and completed the
trial.
The primary endpoint for efficacy was reduction in vertigo
frequency during Month 3 following treatment compared to a one
month baseline period. There were multiple secondary vertigo
endpoints including count of definitive vertigo days, change in
vertigo severity score from baseline, and change in average daily
vertigo count from baseline. Tinnitus was also assessed as an
exploratory endpoint in the study. Additional information about
study protocol can be found at www.clinicaltrials.gov using the
study identifier NCT01412177.
About OTO-104
OTO-104, which has been granted Fast Track designation by the
U.S. Food and Drug Administration (FDA), is a sustained-exposure
formulation of the steroid dexamethasone in development for the
treatment of Ménière's disease and other inner ear conditions.
Otonomy has completed a randomized, prospective, double-blind,
placebo-controlled, Phase 1b clinical trial of a single IT
injection of OTO-104 in patients with Ménière's disease. Results
demonstrated that OTO-104 was well tolerated when administered as a
single IT injection, and 12 mg of OTO-104 was associated with
clinically meaningful improvements in both vertigo frequency and
tinnitus compared to placebo three months after treatment. There
were no serious adverse events observed during the clinical trial.
A Phase 2b single-dose efficacy trial has recently been completed
with a total of 154 Ménière's disease patients. Top-line results
indicate that OTO-104 narrowly missed the primary efficacy endpoint
(p=0.067) but achieved statistical significance (p<0.05) for
multiple prospectively defined secondary vertigo endpoints at
multiple time points. Based on these results Otonomy intends to
initiate two parallel Phase 3 trials, with one of the trials
initiated by the end of 2015. OTO-104 is also being evaluated in a
multiple-dose safety study in the United Kingdom in patients with
Ménière's disease, and enrollment has been completed with a total
of 128 patients.
About Ménière's Disease
Ménière's disease is a chronic condition characterized by acute
vertigo attacks, tinnitus, fluctuating hearing loss and a feeling
of aural fullness. Of these symptoms, the vertigo attacks are
typically most troubling for patients since they disrupt daily
activities and are difficult to anticipate and manage. In general,
patients are diagnosed with unilateral Ménière's disease in middle
age and symptoms often continue for decades. Over time, the
fluctuating hearing loss becomes permanent in many patients, and a
subset of patients will develop symptoms in their second ear.
According to the National Institute of Deafness and Other
Communication Disorders, there are more than 600,000 patients
diagnosed with Ménière's disease in the United States. There is no
known cure for Ménière's disease and there are currently no
FDA-approved drug treatments.
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 middle and
inner ear following a single intratympanic injection. 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 a New Drug Application for AuriPro in this indication
is currently under FDA review. OTO-104 is a steroid that has
recently 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 includes forward-looking statements that are
based on Otonomy's current plans, expectations, estimates and
projections. These forward-looking statements include, but
are not limited to, statements that the OTO-104 Phase 2b data
provides a strong basis to move forward into two parallel Phase 3
trials, Otonomy's plans to request an End-of-Phase 2 meeting
with the FDA, Otonomy's intention to initiate two parallel Phase 3
trials in Ménière's disease with one of the trials initiated by the
end of 2015, other plans with respect OTO-104, and any related
statements. Factors that could cause Otonomy's results to
differ materially from those expressed in forward-looking
statements include, without limitation, the risk that further
analysis of the OTO-104 Phase 2b data changes Otonomy's views on
the results of the OTO-104 Phase 2b clinical trial and related
plans; delays in meeting with FDA or completing those meetings; 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,
future clinical results for its product candidates, which may not
support further development of product candidates, and challenges
related to patient enrollment in clinical trials; the Company's
ability to obtain regulatory approval for its product candidates;
failure to achieve favorable results in clinical trials; the
possibility that product candidates may cause serious adverse side
effects or have properties that delay or prevent regulatory
approval or limit their commercial profile; 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.
The factors referred to above that could cause Otonomy's results
to differ materially from those expressed or implied by such
forward-looking statements also include the risks, uncertainties
and assumptions discussed from time to time in Otonomy's public
filings and public announcements, including Otonomy's Quarterly
Report on Form 10-Q for the quarter ended March 31, 2015 which was
filed with the Securities and Exchange Commission ("SEC") on May
12, 2015, as well as other documents that may be filed by Otonomy
from time to time with the SEC.
CONTACT: Media Inquiries
Canale Communications
Heidi Chokeir, Ph.D.
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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