– In SAKURA 3, RT002 was well-tolerated across over 3,800 treatmentsin glabellar (frown) lines –
– The median time to return to baseline glabellar line severity was 28 weeks –
– RT002 represents the first long-acting neuromodulator, allowing for two or fewer treatments per year –
– Revance announces new trials in forehead lines and lateral canthal lines (crow’s feet) –
– Revance to host conference call at
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As a component of the largest clinical program of an aesthetic neuromodulator, the SAKURA 3 study included nearly 2,700 patients and more than 3,800 treatments. Patients received up to three treatments of RT002 and were followed for over a year and a half. Overall, the safety findings were consistent with the known safety profiles for currently available neuromodulators in aesthetics. Importantly, the rate of treatment-related adverse events decreased over successive treatments. For efficacy, based on investigator assessment, more than 95% of patients achieved a score of none or mild glabellar lines at maximum frown at Week 4 after each of three treatments. Measuring duration of effect, the median time to return to baseline glabellar line severity was 28 weeks. The median time to loss of none or mild wrinkle severity was 24 weeks. The SAKURA 3 results were consistent with those in the Phase 3 pivotal trials, SAKURA 1 and SAKURA 2.
“The results of this trial are exceptional since they demonstrate that
RT002 has consistently and predictably produced long duration and high
response rates and was well tolerated over successive treatments,” said
SAKURA investigator
Following these results, Revance today announced it will begin studies in 2019 in forehead and lateral canthal lines (crow’s feet) to explore the use and dosage of RT002 in the upper face.
“The long-term results in these studies, which are consistent and
predictable across age groups and prior toxin experience, are extremely
impressive,” said SAKURA investigator Steven Fagien, M.D., FACS,
Aesthetic Eyelid Plastic Surgery,
Global sales of neuromodulators totaled
According to findings from a proprietary landmark survey of more than 2,000 women aged 25-70 conducted on behalf of Revance by The Harris Poll,* facial lines and wrinkles are the most concerning visible sign of aging among women in this age range. Still, only seven percent of women said they have used a neuromodulator in the past five years. In addition, the survey also included 246 dermatologists and plastic surgeons who see at least 15 patients a week who receive neuromodulator treatments. Among this group of physicians, 86 percent wish there was a neuromodulator that offered longer-lasting results than what is currently available.
SAKURA 3 TOP-LINE RESULTS
The SAKURA program targeted enrollment of at least 2,600 patients to receive at least one treatment and 500 to receive three treatments with RT002. The topline results include data from 2,691 subjects with moderate-to-severe glabellar lines who were treated with RT002 (40U); 2,380 patients received Treatment #1, 882 patients received Treatment #2, and 568 patients received all three treatments. In general, results across safety, efficacy and duration measures were consistent and predictable across age groups and prior toxin experience.
SAFETY
RT002 appeared to be generally well-tolerated, with no new tolerability or safety concerns reported. As was seen in the SAKURA 1 and SAKURA 2 pivotal trials, adverse events were mild, localized and transient. The rate of treatment-related adverse events decreased over successive treatments. The most common treatment-related adverse events per treatment of RT002 were headache (3.3 percent of treatments), injection site pain (2.7 percent) and injection site erythema (2.5 percent). There were no treatment-related serious adverse events. Eyelid ptosis was reported in 0.9 percent of treatments, decreased in frequency with successive treatments and was substantially lower than the rate observed in SAKURA 1 and SAKURA 2 (2.2 percent). The majority of ptosis events were characterized as mild in severity (85 percent) and transient.
EFFICACY
A high degree of efficacy was seen consistently across all three treatment cycles. Results were consistent with SAKURA 1 and SAKURA 2 based on the Investigator Global Assessment-Facial Wrinkle Severity (IGA-FWS) and Patient Facial Wrinkle Severity (PFWS) scales. As early as Week 1, over 90 percent of subjects across all three treatments had none or mild wrinkles.
At Week 4, the none or mild response rates as assessed by IGA-FWS were:
- SAKURA 3: First treatment 95.8 percent; second treatment 96.6 percent; third treatment 97.7 percent
- SAKURA 1: 97.5 percent
- SAKURA 2: 97.5 percent
On the more stringent 2-point composite endpoint, which was the primary efficacy endpoint in SAKURA 1 and 2, efficacy improved with successive treatment cycles:
- SAKURA 3: First treatment 73.2 percent; second treatment 77.7 percent; third treatment 79.6 percent
- SAKURA 1: 73.6 percent
- SAKURA 2: 74.0 percent
DURATION
As in the SAKURA 1 and SAKURA 2 pivotal trials, there were several secondary endpoints used to evaluate duration of effect, including median time to loss of none or mild wrinkle severity on both IGA-FWS and PFWS, and median duration for time to return to baseline wrinkle severity on both IGA-FWS and PFWS. Duration was evaluated in the first two 36-week treatment cycles; the third treatment cycle was not evaluated for duration as the observation period ended at twelve weeks for the purpose of this study.
Median time to return to baseline wrinkle severity on both IGA-FWS and PFWS:
- SAKURA 3: First treatment 28.0 weeks; second treatment 28.1 weeks
- SAKURA 1: 27.7 weeks
- SAKURA 2: 26.0 weeks
Median time to loss of none or mild wrinkle severity on both IGA-FWS and PFWS:
- SAKURA 3: First treatment 24.0 weeks; second treatment 24.1 weeks
- SAKURA 1: 24.0 weeks
- SAKURA 2: 23.9 weeks
About SAKURA Phase 3 Clinical Program
The SAKURA Phase 3 clinical program is the largest-ever aesthetic neuromodulator clinical program, including nearly 2,800 patients who received, in total, more than 4,200 treatments with RT002.
The SAKURA program included SAKURA 1 and SAKURA 2 – two randomized,
double-blind, placebo-controlled pivotal trials that were identical in
design to evaluate the safety and efficacy of a single administration of
RT002 for the treatment of moderate-to-severe glabellar lines in adults
from 18 to 75 years of age --and SAKURA 3, an open-label trial designed
to evaluate the long-term safety of RT002 in glabellar lines following
both single and repeat treatment administration in adults 18 years and
older. The SAKURA 1 and SAKURA 2 trials enrolled a total of 609 patients
at 30 sites in the U.S. and
The SAKURA 3 long-term safety trial enrolled 2,691 patients at 66 sites
in the U.S. and
About Glabellar Lines
The glabella is the area between the eyebrows and above the nose. Glabellar lines, often called “frown lines,” are vertical lines that develop between the eyebrows and may appear as a single vertical line or as two or more lines. When you frown, the muscles of the glabella contract causing vertical creases to form between the eyebrows. Botulinum toxin is used to temporarily block the ability of nerves to trigger contraction of injected muscle, inhibiting movement of the muscles that cause the frown lines, giving the skin a smoother, more refreshed appearance.
Based on data from
About RT002
DaxibotulinumtoxinA for Injection (RT002) is an investigational product and the first neuromodulator with long-lasting duration. It is a novel, next-generation neuromodulator in development for the treatment of aesthetic indications and a number of potential therapeutic conditions, including movement disorders, pain and other neuroscience-based targets. RT002 is the only neuromodulator using a Revance proprietary stabilizing excipient peptide technology in its formulation, which results in high efficacy, long duration and provides two-year product stability requiring no refrigeration. RT002 is the first and only botulinum toxin product sourced, processed and manufactured in the U.S. and formulated without human blood-derived products or manufactured using animal-derived proteins.
Revance has four active clinical programs for RT002 injectable under
way. The SAKURA 1, SAKURA 2 and SAKURA 3 trials to treat glabellar lines
are complete. For cervical dystonia, the company was granted orphan drug
designation from the
Conference Call
Individuals interested in listening to the conference call may do so by dialing (855) 453-3827 for domestic callers, or (484) 756-4301 for international callers and reference conference ID: 2281019; or from the webcast link in the investor relations section of the company's website at: www.revance.com.
A replay of the call will be available beginning
About
“Revance Therapeutics” and the Revance logo are registered trademarks of
*Method Statement -This survey was conducted online by The Harris Poll
on behalf of Revance among women aged 25-70 and Dermatologists and
Plastic Surgeons who see patients who receive neuromodulator treatments
in
Forward-Looking Statements
This press release contains forward-looking statements, including
statements related to
Forward-looking statements are subject to risks and uncertainties
that could cause actual results to differ materially from our
expectations. These risks and uncertainties include, but are not limited
to: the outcome, cost, and timing of our product development activities
and clinical trials; the uncertain clinical development process,
including the risk that clinical trials may not have an effective design
or generate positive results, or that positive results would assure
regulatory approval or commercial success of our product candidates; our
ability to obtain and maintain regulatory approval of our drug product
candidates; our ability to obtain funding for our operations; our plans
to research, develop, and commercialize our drug product candidates; our
ability to achieve market acceptance of our drug 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 our
drug product candidates; our ability to successfully commercialize our
drug product candidates and the timing of commercialization activities;
the rate and degree of market acceptance of our drug product candidates;
our ability to develop sales and marketing capabilities; the accuracy of
our estimates regarding expenses, future revenues, capital requirements
and needs for financing; our ability to continue obtaining and
maintaining intellectual property protection for our drug product
candidates; and other risks. Detailed information regarding factors that
may cause actual results to differ materially from the results expressed
or implied by statements in this press release may be found in Revance's
periodic filings with the Securities and Exchange Commission (the
"SEC"), including factors described in the section entitled "Risk
Factors" of our quarterly report on Form 10-Q filed
View source version on businesswire.com: https://www.businesswire.com/news/home/20181204005591/en/
Source:
INVESTORS
Revance Therapeutics, Inc.:
Jeanie Herbert
714-325-3584
jherbert@revance.com
Burns McClellan, Inc.:
Ami Bavishi
212-213-0006
abavishi@burnsmc.com
MEDIA
General Media:
TOGORUN:
Mariann Caprino
917-242-1087
m.caprino@togorun.com
Trade Media:
Nadine Tosk
504-453-8344
nadinepr@gmail.com
