Loading...
Loading...
Revance Therapeutics, Inc.
, 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.
Loading...
Loading...
© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
Benzinga simplifies the market for smarter investing
Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.
Join Now: Free!
Already a member?Sign in