– Highly statistically significant results on
primary composite endpoint achieved at Week 4 –
– RT002 delivered highly statistically
significant reduction in severity of glabellar lines at Week 24
–
– If approved, RT002 could represent a new,
next-generation, long-acting neuromodulator –
– Revance to host conference call at 8:00 am ET
today –
Revance Therapeutics, Inc. (NASDAQ:RVNC), a biotechnology
company developing neuromodulators for use in treating aesthetic
and underserved therapeutic conditions, today announced its
next-generation neuromodulator DaxibotulinumtoxinA for Injection
(RT002) delivered positive top-line results in alleviating
moderate-to-severe glabellar lines in two pivotal SAKURA Phase 3
trials. RT002 appeared generally safe and well-tolerated in both
studies.
If approved by the U.S. Food and Drug Administration (FDA),
Revance believes RT002 would be the first neuromodulator with a
long-acting duration of six months. Marketed neuromodulators have
demonstrated duration of three to four months in treating glabellar
lines.
Both SAKURA 1 and SAKURA 2 met the primary composite endpoint by
delivering highly statistically significant improvement against
placebo in reducing the severity of glabellar lines, i.e., the
frown lines or wrinkles between the brows. The percent of
RT002-treated patients who had none or mild wrinkles and achieved
at least a two-point improvement from baseline on both validated
physician and patient assessments were 73.6 percent in SAKURA 1 and
74.0 percent in SAKURA 2 compared to placebo (p<0.0001) at Week
4. Also at that time point, 88 percent of RT002-treated patients in
SAKURA 1 and 91 percent of RT002 patients in SAKURA 2 said they
were very satisfied or satisfied with their treatment
experience.
All secondary endpoints measuring reduction in severity of
glabellar lines with RT002 compared to placebo were highly
statistically significant at every time point evaluated to 24
weeks. On an additional key secondary endpoint, median duration for
patients treated with RT002 to return to baseline wrinkle severity
was nearly 27 weeks (SAKURA 1: 27.7 weeks and SAKURA 2: 26.0 weeks)
as assessed by both physicians and patients.
“We are extremely pleased with these positive SAKURA top-line
results, which reinforce the findings from the BELMONT Phase 2
active-comparator study. These results demonstrate it is
scientifically and clinically possible to create a significantly
longer-acting neuromodulator with a duration of six months,
compared to three to four months observed with currently available
products,” said Dan Browne, Co-Founder, President and Chief
Executive Officer of Revance Therapeutics. “We look forward to
providing patients and healthcare professionals with what we
believe is a new, next-generation, long-acting neuromodulator for
the treatment of glabellar lines.”
In addition to SAKURA 1 and SAKURA 2, a long-term safety trial,
SAKURA 3, is fully enrolled and is expected to be completed in the
second half of 2018. Assuming successful completion of SAKURA 3,
the company plans to submit a Biologics License Application in the
first half of 2019 and, pending approval by the FDA, launch RT002
in the U.S. in 2020.
“Both SAKURA 1 and SAKURA 2 show RT002 delivers consistent
long-acting performance, which is unprecedented for a
neuromodulator given what we have seen over the last 30 years,”
said Jean D. Carruthers, M.D., a SAKURA lead investigator and
pioneer in the use of botulinum toxin for both aesthetic and
therapeutic conditions, and Clinical Professor, University of
British Columbia. “The data confirm the enhanced effect of this new
neuromodulator both in its longevity and patient response. With
just two treatments a year, RT002 has the potential to change the
landscape in neuromodulator therapy.”
Treatment of glabellar lines is the most popular aesthetic
procedure for an injectable neuromodulator, accounting for nearly a
third of the $3.6 billion in global neuromodulator sales in 2016.
Patients and physicians alike identify duration as the most
important attribute of an injectable aesthetic treatment, market
research shows. 1
“Patients in my practice are very savvy – not only do they want
their neuromodulator treatment to give them great results, they
also want the look to last as long as possible,” said Joely
Kaufman-Janette, M.D., Skin Associates of South Florida, and a
SAKURA investigator. “I am very excited about the results of the
SAKURA trials since RT002 appears to provide the look my patients
desire over a six-month period, which is remarkable and will
fulfill a significant need among my patients.”
TOP-LINE 36-WEEK RESULTS
PRIMARY ENDPOINT
The primary efficacy measurement was a composite of the
proportion of patients who achieved a score of 0 or 1 (none or
mild) and at least a two-point improvement from baseline at maximum
contraction (frown) in glabellar line severity on both the
Investigator Global Assessment-Facial Wrinkle Severity (IGA-FWS)
and Patient Facial Wrinkle Severity (PFWS) scales at Week 4.
- Percent of patients who achieved the
primary composite endpoint:
- SAKURA 1: 73.6 percent of patients vs.
0 percent for placebo (p<0.0001)
- SAKURA 2: 74.0 percent vs. 1.0 percent
for placebo (p<0.0001)
SECONDARY DURATION ENDPOINTS
There were several secondary endpoints used to evaluate duration
of effect, including the proportion of patients achieving none or
mild response on IGA-FWS compared to placebo, median duration for
time to loss of none or mild wrinkle severity on both IGA-FWS and
PFWS, and median duration for time to return to baseline on both
IGA-FWS and PFWS.
- The percent of patients treated with
RT002 who achieved a none or mild response on IGA-FWS at Week 24:
- SAKURA 1: 35.3 percent vs. 2.0 percent
for placebo (p<0.0001)
- SAKURA 2: 29.4 percent vs. 2.0 percent
for placebo (p<0.0001)
- Median duration for time to loss of
none or mild wrinkle severity on both IGA-FWS and PFWS for patients
treated with RT002:
- SAKURA 1: 24.0 weeks
- SAKURA 2: 23.9 weeks
- Median duration for time to return to
baseline wrinkle severity on both IGA-FWS and PFWS for patients
treated with RT002:
- SAKURA 1: 27.7 weeks
- SAKURA 2: 26.0 weeks
For comparison, an additional exploratory duration endpoint was
evaluated, which mirrors the duration measure used in the BELMONT
Phase 2 study.
- Median duration of ≥ 1 point
improvement from baseline on IGA-FWS for patients treated with
RT002:
- SAKURA 1: 24.1 weeks
- SAKURA 2: 24.1 weeks
- BELMONT: 23.6 weeks2
SAFETY
RT002 appeared to be generally safe and well-tolerated through
the end of study at Week 36. Adverse events were mild, localized
and transient. There were no treatment-related serious adverse
events. The most common adverse events for RT002 in both studies
combined were headache (6.4 percent) and injection site pain (3.7
percent). The incidence of eyelid ptosis and brow ptosis were 2.2
percent and 0.7 percent, respectively.
About SAKURA Phase 3 Clinical Program
The SAKURA clinical program includes 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. The SAKURA 1 and SAKURA 2 trials enrolled a total of 609
patients at 30 sites in the U.S. and Canada. In both trials,
patients were randomized 2:1 to receive either RT002 (40U) or
placebo. Post-treatment, patients were followed for at least 24
weeks and up to 36 weeks.
The primary efficacy endpoint was the composite of the
proportion of patients who achieved a score of 0 or 1 (none or
mild) and at least two-point improvement from baseline in glabellar
line severity on both the Investigator Global Assessment-Facial
Wrinkle Severity (IGA-FWS) and Patient Facial Wrinkle Severity
(PFWS) scales, at maximum contraction (frown), at Week 4. Duration
of the reduction of severity of glabellar lines was assessed as
secondary efficacy endpoints.
The program also includes an open-label trial designed to
evaluate the long-term safety of RT002 in glabellar lines following
both single and repeat treatment administration. The long-term
safety trial enrolled more than 2,500 patients at 66 sites in the
U.S. and Canada and is expected to be completed in the second half
of 2018.
About Glabellar Lines
The glabella is the skin 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 and may also appear angled
toward the inner corners of the eyebrows. When you frown, the
muscles of the lower forehead contract in a downward direction,
causing the skin between the eyebrows to crease. Lines are formed
by the repeated action of frowning due to the lack of elasticity in
the skin. Age, sun exposure, and genetics are contributing factors.
Botulinum toxin is used to block the nerve impulses, temporarily
inhibiting movement of the muscles that cause the frown lines,
giving the skin a smoother, more refreshed appearance.
Based on data from Global Industry Analysts, Inc., the global
market for aesthetic treatments with neuromodulators represented
about $1.6 billion in revenue in 2016, and according to the
American Society for Aesthetic Plastic Surgery, botulinum toxin
treatment is the No.1 nonsurgical cosmetic procedure in the U.S.
Management estimates glabellar line treatment represents nearly $1
billion of the global market.
About RT002
DaxibotulinumtoxinA for Injection (RT002) is an investigational
product. It is a novel, next-generation neuromodulator in
development for the treatment of aesthetic and therapeutic
conditions, including glabellar lines, cervical dystonia and
plantar fasciitis. Created using Revance’s proprietary peptide
technology, RT002 has the potential to become the first
neuromodulator with long-acting duration of six months. This
proprietary, stabilizing excipient peptide technology eliminates
the need for human- and animal-based components, which carry a
potential risk of transmitting pathogens.
Revance has three active clinical programs for RT002 injectable
under way. With the SAKURA 1 and SAKURA 2 Phase 3 pivotal trials to
treat glabellar lines now completed, Revance plans to complete the
SAKURA 3 open-label, long-term safety study in the second half of
2018. For cervical dystonia, the company was recently granted
orphan drug designation and plans to initiate a Phase 3 program in
2018. A Phase 2 trial for RT002 for the management of plantar
fasciitis is fully enrolled, and the company plans to share results
by year end 2017.
Conference Call
Individuals interested in listening to the conference call
today, December 5, at 5:00am PT/8:00am ET, may do so by dialing
(855) 453-3827 for domestic callers, or (484) 756-4301 for
international callers and reference conference ID: 9076999; or from
the webcast link in the investor relations section of the Company's
website at: http://investors.revance.com/index.cfm.
A replay of the call will be available beginning today at 8:00am
PT/11:00am ET through 8:00am PT/11:00am ET on December 6, 2017. To
access the replay, dial (855) 859-2056 or (404) 537-3406 and
reference conference ID: 9076999. The webcast will be available in
the investor relations section on the Company's website for 30 days
following the completion of the call.
About Revance Therapeutics, Inc.
Revance Therapeutics is a biotechnology company developing
neuromodulators for use in treating aesthetic and underserved
therapeutic conditions, including muscle movement disorders and
pain. The company’s lead drug candidate, DaxibotulinumtoxinA for
Injection (RT002), is currently in development for the treatment of
glabellar lines, cervical dystonia and plantar fasciitis, with the
potential to be the first long-acting neuromodulator. Revance has
developed a proprietary, stabilizing excipient peptide technology
designed to create novel, differentiated therapies. The company has
a comprehensive pipeline based upon its peptide technology,
including injectable and topical formulations of
daxibotulinumtoxinA. More information on Revance may be found at
www.revance.com.
“Revance Therapeutics” and the Revance logo are registered
trademarks of Revance Therapeutics, Inc.
Forward-Looking Statements
This press release contains forward-looking statements,
including statements related to our business strategy, timeline and
other goals and market for our anticipated products, plans and
prospects; statements about our ability to obtain regulatory
approval; and statements about potential benefits of our drug
product candidates and our technologies.
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; 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 November 3, 2017. These forward-looking statements
speak only as of the date hereof. Revance disclaims any obligation
to update these forward-looking statements.
References:
1. Data on file2. Carruthers, J., et al. Injectable
DaxibotulinumtoxinA for the Treatment of Glabellar Lines: A Phase
2, Randomized, Dose-Ranging, Double-Blind, Multicenter Comparison
with OnabotulinumtoxinA and Placebo. Dermatol. Surg. 2017; 43: 1321
– 1331
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INVESTORSRevance Therapeutics, Inc.Jeanie Herbert,
714-325-3584jherbert@revance.comorBurns McClellan, Inc.Ami Bavishi,
212-213-0006abavishi@burnsmc.comorMEDIAGeneral Media:TOGORUNMariann
Caprino, 917-242-1087m.caprino@togorun.comorTrade Media:Nadine
Tosk, 504-453-8344nadinepr@gmail.com
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