Revance Therapeutics Announces Positive Results From the RT002 Phase 1/2 Study in Glabellar Frown Lines
April 21 2014 - 3:55PM
Revance Therapeutics, Inc. (Nasdaq:RVNC), today announced positive
data from its Phase 1/2 study of RT002 injectable botulinum toxin
type A for the treatment of moderate to severe glabellar (frown)
lines. RT002 is Revance's proprietary, injectable botulinum toxin
investigational product that incorporates the patented TransMTS®
technology and is designed to provide a longer lasting duration of
effect. In the study, RT002 met its primary efficacy and safety
endpoints. The open-label, dose escalating, Phase 1/2 study
enrolled 48 adults in four cohorts. All subjects had Severe or
Moderate wrinkles at baseline, measured using the 4-point Global
Line Severity Scale (GLSS). In summary, the data showed:
- 94% of subjects were rated with None or Mild wrinkle severity
at maximum frown 4 weeks post-treatment using the GLSS as assessed
by the clinical investigator. 83% of subjects assessed themselves
as achieving None or Mild wrinkles at maximum frown at the same
time point.
- In the final cohort, the only one where duration of effect was
measured, RT002 achieved a median duration of 29.4 weeks or 7.3
months based on both investigator and subject assessments.
- RT002 was well tolerated, and there was no evidence of spread
beyond the treatment site at any dose.
Based on the results of this study and previous findings from
pre-clinical data, we plan to continue studying RT002 in a Phase 2
active comparator study. Data from the study is anticipated in
2015.
"RT002 was easy to administer and very well received by
patients," said Enrique Garcia-Murray, MD lead investigator for the
RT002 study. "As the study progressed, we were most impressed by
the duration of effect. Patients typically see three to four months
of benefit from current botulinum toxin treatments, but we saw an
effect that was significantly longer than that. My patients were
extremely happy about this increased duration."
"The results of this study are extremely encouraging from both
safety and efficacy perspectives," said Jacob Waugh, MD, Chief
Scientific Officer and Medical Director. "This data aligns well
with previously reported preclinical studies which established less
unwanted spread and longer duration. We look forward to expanding
our evaluation of RT002 further in Phase 2 studies."
Safety and Tolerability
Across all cohorts, RT002 was shown to be generally safe and
well tolerated with minimal adverse events. An independent Data
Safety Committee (DSC) composed of experts from neurology,
dermatology, and internal medicine, reviewed the data after each
cohort and confirmed the safety of dose escalation prior to each
successive higher dose. Adverse events were generally mild,
localized and transient. The most common adverse events observed
were headache and injection site reactions. There was no evidence
of spread beyond the treatment site at any dose. There were no
serious adverse events or evidence of any systemic exposure based
on clinical laboratory results and related evaluations. Adverse
event rates did not change in frequency, severity, or type with
increasing doses.
Clinical Study Design
RT002-CL001 was a Phase 1/2 dose escalating, open-label study
for the treatment of moderate to severe glabellar (frown) lines.
The study was conducted in Mexico City and enrolled 48 patients
across four dose cohorts, ranging from approximately half the
labeled dose to approximately twice the labeled dose of
commercially available neurotoxins based on potency assays commonly
used in the industry.
The study objective was to establish a safe dose and evaluate
safety, efficacy and durability after a single administration of
RT002 for the treatment of glabellar (frown) lines. Efficacy was
assessed at maximum frown by the investigator and the subjects
using the 4-point GLSS at the 2 and 4-week time points for all
cohorts. The final cohort, consisting of 10 subjects, was also
measured for duration of effect at the six, seven and eight month
time points.
About RT002
RT002, an investigational product, is a novel, injectable form
of botulinum toxin type A currently under evaluation for the
treatment of moderate to severe glabellar (frown) lines. RT002
combines our proprietary, pure 150kD botulinum toxin type A
molecule without any accessory proteins or animal derived
components with the patented TransMTS® peptide technology. It
is designed to be more targeted and longer lasting than currently
available botulinum toxin injectable products. It is being
developed to treat both aesthetic and therapeutic conditions where
deeper, more targeted delivery is required or longer duration is
desired.
About Revance Therapeutics, Inc.
Revance is a specialty biopharmaceutical company focused on the
development, manufacturing and commercialization of novel botulinum
toxin products across multiple aesthetic and therapeutic
applications. The TransMTS® technology platform is the basis for a
suite of novel botulinum toxin products to address many of the
shortcomings of currently available neurotoxins. Our lead product
is RT001 a topically applied formulation of botulinum toxin type A,
which has the potential to be the first commercially-available
non-injectable dose form. RT001 is being evaluated in a broad
clinical program that includes aesthetic indications such as crow's
feet lines (wrinkles around the eyes) and therapeutic indications
such as hyperhidrosis (excessive sweating) and migraine headache.
The Company is leveraging its proprietary portfolio of botulinum
toxin compounds combined with its patented delivery system to
address unmet needs in the large and growing aesthetic and
therapeutic botulinum toxin market.
Forward Looking Statements
This press release contains forward-looking statements,
including statements related to the process and timing of
anticipated future clinical development of Revance Therapeutics'
product candidates, including continued plans to study RT002 in a
Phase 2 clinical trial, with anticipated results in 2015;
statements about its business strategy and goals; and potential
benefits of its product candidates and
technologies. Forward-looking statements are subject to risks
and uncertainties that could cause actual results to differ
materially from Revance's expectations. These risks and
uncertainties include, but are not limited to: the outcome, cost
and timing of its product development activities and clinical
trials; the uncertain clinical development process, including the
risk that clinical trials may not have an effective design;
Revance's ability to obtain and maintain regulatory approval of its
product candidates; its ability to obtain funding for its
operations; its plans to research, develop and commercialize its
product candidates; its ability to achieve market acceptance of its
product candidates; unanticipated costs or delays in research,
development and commercialization efforts; the applicability of
clinical study results to actual outcomes; the size and growth
potential of the markets for its product candidates; its ability to
successfully commercialize its product candidates and the timing of
commercialization activities; the rate and degree of market
acceptance of its product candidates; its ability to develop sales
and marketing capabilities; the accuracy of its estimates regarding
expenses, future revenues, capital requirements and needs for
financing; its ability to continue obtaining and maintaining
intellectual property protection for its product candidates; and
other risks detailed in the "Risk Factors" and elsewhere in
Revance's U.S. Securities and Exchange Commission filings and
reports, including its Annual Report on Form 10-K filed with the
SEC on March 28, 2014. These forward-looking statements speak only
as of the date hereof. Revance disclaims any obligation to update
these forward-looking statements.
CONTACT: Westwicke Partners
Ana Petrovic
(415) 513-1281
ana.petrovic@westwicke.com
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