European and Canadian Phase III study shows DWP 450 non inferior to onabotulinumtoxinA for treatment of glabellar lines. Evolus.Inc.

Evolus, Inc. announced the presentation of data from the Phase III comparative clinical trial of its investigational prabotulinumtoxinA 900 kilodalton (kDa) neuromodulator at the American Academy of Dermatology (AAD) meeting. The European and Canadian Phase III study, EVB-003 , was presented by Berthold Rzany, M.D during the AAD meeting on Saturday, February 17, 2018.

In the study, prabotulinumtoxinA and onabotulinumtoxinA, both 900 kDa botulinum toxin type A complexes, were studied in subjects with glabellar lines, also known as "frown lines" between the eyebrows.

About the Phase III EVB-003 Study- EVB-003 was a 150-day, multicenter, randomized, double-blind, active- and placebo-controlled, single-dose Phase III non-inferiority study. 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), were enrolled provided that they also felt their glabellar lines had an important psychological impact. 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 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 adverse event assessed as study-drug related was 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.