Evolus Phase III European - Canadian Head-to-Head Trial of prabotulinumtoxinA Compared to Botox® Meets Primary Endpoint
April 05 2018 - 7:30AM
Evolus, Inc. (NASDAQ:EOLS) (“Evolus”), a medical aesthetics company
focused on delivering advanced aesthetic procedures and treatments
to physicians and consumers, today announced the presentation of
data from the European and Canadian Phase III EVB-003 head-to-head
comparative trial demonstrating that its investigational
prabotulinumtoxinA 900 kilodalton (kDa) neuromodulator met its
primary endpoint of non-inferiority at Day 30 in subjects with
moderate to severe glabellar lines, also known as "frown lines,"
compared to onabotulinumtoxinA (Botox®).
The results were presented today in a poster
titled “A Multicenter Phase III Study Comparing prabotulinumtoxinA
and onabotulinumtoxinA for the Treatment of Glabellar Lines” by Dr.
Patricia Ogilvie, M.D., dermatologist and Principal Investigator of
the study, at the 2018 Aesthetic & Anti-Aging Medicine World
Congress (AMWC), being held April 4-7 in Monte-Carlo, Monaco. The
results presented at AMWC expand upon the initial results presented
at the American Academy of Dermatology (AAD) annual meeting in
February 2018.
“Analysis of this study presented at AMWC shows
that prabotulinumtoxinA met its primary endpoint in efficacy as
well as its secondary endpoints. In particular, the secondary
endpoint of subject satisfaction is important because it represents
the opinions of consumers who underwent the treatment,” commented
Patricia Ogilvie, M.D. “Based on these findings, we believe that
prabotulinumtoxinA represents a compelling and innovative option
for the aesthetic treatment of glabellar lines.”
“The presentation of this expanded data set from
the EVB-003 comparative study is another significant milestone in
the prabotulinumtoxinA development program,” Rui Avelar, M.D.,
Chief Medical Officer of Evolus. “It further expands and supports
the growing body of clinical data suggesting that our product
candidate has the potential to be efficacious in the treatment of
glabellar lines with a favorable safety profile.”
EVB-003 was a 150-day, multicenter, randomized,
double-blind, active- and placebo-controlled, single-dose Phase III
non-inferiority study evaluating prabotulinumtoxinA and
onabotulinumtoxinA, both 900 kDa botulinum toxin type A complexes,
in subjects who felt their glabellar lines had an important
psychological impact. Adults aged 18 or older with moderate to
severe glabellar lines at maximum frown, as assessed by the
investigator on the 4-point Glabellar Line Scale (GLS, 0=no lines,
1=mild, 2=moderate, 3=severe), who met these criteria were
enrolled. Randomization was 5:5:1 to receive a single treatment of
20 U prabotulinumtoxinA, 20 U onabotulinumtoxinA or placebo (0.9%
saline). The primary efficacy endpoint was measured on Day 30 and a
responder was defined as a GLS score of 0 or 1 at maximum frown as
assessed by the investigator. A total of 540 subjects were
enrolled: 245 received prabotulinumtoxinA; 246 received
onabotulinumtoxinA; and 49 received placebo. The study met the
primary endpoint of non-inferiority at Day 30 with responder rates
of 87.2% in the prabotulinumtoxinA group, 82.8% in the
onabotulinumtoxinA group, and 4.2% in the placebo group. The
absolute differences between prabotulinumtoxinA and placebo groups,
and between onabotulinumtoxinA and placebo groups were 83.1% and
78.6%, respectively (both p<0.001). The absolute difference
between the prabotulinumtoxinA and onabotulinumtoxinA groups was
4.4%; 95% confidence interval or CI (-1.9, 10.8). The lower bound
of the 95% CI for the difference was greater than -10.0% therefore
non-inferiority of prabotulinumtoxinA versus onabotulinumtoxinA was
achieved. The study concluded that a single dose of 20 U
prabotulinumtoxinA was non-inferior to 20 U onabotulinumtoxinA for
the treatment of moderate to severe glabellar lines. The
percentages of subjects experiencing adverse events assessed
as study-drug related were 15.5%, 14.6% and 4.1% in the
prabotulinumtoxinA, onabotulinumtoxinA and placebo groups,
respectively. There were no serious adverse events that were
assessed as study-drug related.
About PrabotulinumtoxinA
PrabotulinumtoxinA is a 900 kDa purified botulinum toxin type A
complex. The product candidate's Biologics License Application
(BLA) is currently under review by the U.S. Food and Drug
Administration (FDA). The product candidate's Marketing
Authorization Application (MAA) is currently also under review by
the European Medicines Agency (EMA). The FDA application is for the
temporary improvement in the appearance of moderate to severe
glabellar lines associated with corrugator and/or procerus muscle
activity in adults. The EMA application is for temporary
improvement in the appearance of moderate to severe vertical lines
between the eyebrows seen at maximum frown (glabellar lines), when
the severity has an important psychological impact in adult
patients.
About Evolus, Inc.Evolus is a
medical aesthetics company dedicated to bringing advanced aesthetic
procedures and treatments to physicians and consumers. Evolus
focuses on the self-pay aesthetic market and its lead product
candidate DWP-450 (prabotulinumtoxinA neuromodulator), an
injectable 900 kDa purified botulinum toxin type A complex.
Evolus Contacts:
Media:Kirsten Thomas, The Ruth GroupTel: +1-508-280-6592Email:
kthomas@theruthgroup.com
Investor Contact:Brian Johnston, The Ruth Group Tel: +1
646-536-7028Email: IR@Evolus.com
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