Novan Announces Full Top Line Results from Phase 2 Molluscum Contagiosum Clinical Trial and Decision to Move Forward with SB2...
December 10 2018 - 7:30AM
Novan, Inc. ("the Company" or "Novan") (NASDAQ:NOVN) today
announced full top line results from the Company’s Phase 2 clinical
trial to evaluate topical nitric oxide product candidate SB206 for
the treatment of molluscum contagiosum, including results from the
fourth cohort, SB206 12% once-daily. Results demonstrated a clear
treatment effect on the complete clearance of all molluscum lesions
at Week 12 for 12% once-daily SB206 gel, with signs of efficacy
evident as early as Week 2. The safety and tolerability profiles
for all treatment groups were favorable, with no serious adverse
events reported. Preliminary top line results from the first three
cohorts, 4%, 8% and 12% twice-daily, were announced in November.
Novan conducted a 12-week, randomized,
double-blind, vehicle-controlled, ascending dose Phase 2 trial to
evaluate four treatment groups of 4%, 8% or 12% twice-daily or 12%
once-daily, and vehicle as a treatment for molluscum. Key
characteristics of this trial include:
- Number of patients: 256 total; 190 with SB206 and 66 with
vehicle.
- Inclusion criteria: Ages 2 years and older, with 3 to 70
molluscum lesions.
- Primary endpoint: Complete clearance of all molluscum lesions
at Week 12.
- Primary statistical analysis: Prespecified as Modified
Intent-to-Treat (mITT), consisting of all patients who were
randomized and completed the study treatment. A sensitivity
analysis of the primary endpoint was repeated using the
Intent-to-Treat (ITT) population.
Results from 12% once-daily are consistent with
and support previously announced results from 4%, 8% and 12%
twice-daily:
- For the primary endpoint, 12% once-daily was the most effective
dose with 42% (mITT, p<0.05) and 38% (ITT, p<0.05) complete
clearance rates compared to 20% and 18% for vehicle,
respectively.
- For the secondary endpoint of mean percent change from baseline
molluscum lesion count at each visit, patients treated with 12%
once-daily experienced 29% (p<0.05), 37% (p<0.01), 56%
(p<0.001) and 55% reductions in molluscum lesions at Week 2, 4,
8 and 12, respectively (mITT).
- The 12% once-daily treatment group had the lowest dropout rate
out of all treatment groups, 9%, with 0 patients discontinuing
treatment due to adverse event.
“The consistency in the trial results with 8%
and 12% twice-daily and now 12% once-daily is very encouraging,”
stated Paula Brown Stafford, Novan’s Chief Development Officer.
“The 12% once-daily dose has several key characteristics that would
make it the optimal choice going forward from both a clinical and
commercial perspective, including high complete clearance rates and
a treatment benefit as soon as Week 2. SB206, as a once-daily,
at-home, caregiver-applied, safe and well tolerated topical
therapy, if approved, would benefit a significant number of
patients currently facing an inadequate treatment paradigm.”
With the full results from this Phase 2 trial
now available, the Company intends to request, by the end of
December, an end-of-Phase 2 meeting with the FDA. This meeting
would enable Novan and the FDA to agree on a Phase 3 development
plan for molluscum with SB206 12% once-daily as the active
treatment arm. Following a successful end-of-Phase 2 meeting with
the FDA, the Company plans to initiate a Phase 3 program of SB206
for molluscum in the first half of 2019 with top line results
possible by the end of 2019 or early in 2020.
About Molluscum Contagiosum
Molluscum contagiosum is a common, contagious
skin infection caused by the molluscipoxvirus, affecting
approximately six million people in the U.S. annually, with the
greatest incidence in children aged one to 14 years. Infected
children typically present with 10 to 30 painless, yet unsightly
lesions, and, in severe cases, they can have around 100 lesions.
Due to the largely pediatric nature of the disease, parents are the
caregivers for these children, in most cases, and tend to seek
treatment. There are no FDA approved therapies for molluscum, and,
upon seeking treatment, caregivers are faced with potentially
painful in-office, dermatologist-administered physical procedures
or cantharidin, or recommended off-label prescriptions and
over-the-counter products. More than half of the patients diagnosed
with molluscum are untreated and over 30% of those treated receive
an off-label prescription with no molluscum indication or proven
clinical efficacy. The average time to resolution is 13 months,
however, some children experience lesions that may not resolve in
24 months. Further dissemination of this highly-contagious disease
is common, and transmission to other children living in the
household is reported to be 41%. There is a significant unmet need
in the molluscum treatment landscape.
About Novan
Novan, Inc. is a clinical-stage biotechnology
company focused on leveraging nitric oxide’s natural antiviral and
immunomodulatory mechanisms of action to treat dermatological and
oncovirus-mediated diseases. We believe that our ability to
conveniently deploy nitric oxide in a solid form, on demand and in
localized formulations allows us the potential to significantly
improve patient outcomes in a variety of diseases.
Forward-Looking Statements
This press release contains forward-looking
statements including, but not limited to, statements related to
pharmaceutical development of nitric oxide-releasing product
candidates, our intention to advance the development of SB206 for
the treatment of molluscum, which is subject to our ability to
obtain additional financing or enter into strategic relationships
to enable such development, and the future prospects of our
business and our product candidates. Forward-looking statements are
subject to a number of risks and uncertainties that could cause
actual results to differ materially from our expectations,
including, but not limited to: risks and uncertainties in the
clinical development process, including, among others, length,
expense, ability to enroll patients, reliance on third parties, and
that results of earlier research and preclinical or clinical trials
may not be predictive of results, conclusions or interpretations of
later research or trials; risks related to the regulatory approval
process, which is lengthy, time-consuming and inherently
unpredictable; our ability to obtain substantial additional funding
for the further advancement and development of our product
candidates; our ability to identify and enter into strategic
relationships for the further development and potential
commercialization of our product candidates; and other risks and
uncertainties described in our annual report filed with the SEC on
Form 10-K for the twelve months ended Dec. 31, 2017, and in our
subsequent filings with the SEC. These forward-looking statements
speak only as of the date of this press release, and Novan
disclaims any intent or obligation to update these forward-looking
statements to reflect events or circumstances after the date of
such statements, except as may be required by law.
CONTACT:
(Investors & Media)Cole IkkalaDirector, Investor Relations
& Business Developmentcikkala@novan.com
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