Apr 05, 2018
Evolus Phase III European - Canadian Head-to-Head Trial of prabotulinumtoxinA Compared to Botox® Meets Primary Endpoint
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.
“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
“The presentation of this expanded data set from the EVB-003 comparative study is another significant milestone in the prabotulinumtoxinA development program,”
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.
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
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