Allergan Reports Positive Topline Results From Studies of TrenibotulinumtoxinE for Glabellar Lines
BoNT/E is a novel botulinum neurotoxin serotype E characterized by a rapid onset of action as early as 8 hours after administration and short duration of effect within 2-3 weeks.
Allergan Aesthetics’ trenibotulinumtoxinE (BoNT/E) performed well for the treatment of moderate to severe glabellar lines, according to topline results from two pivotal Phase 3 studies.
BoNT/E is a novel botulinum neurotoxin serotype E with a quick onset of action of as early as eight hours and a short duration of effect of around two to three weeks after administration.
The Phase 3 multicenter, randomized, double-blind, placebo-controlled studies evaluated the safety and efficacy of BoNT/E versus placebo in a total of 947 adult subjects with moderate to severe glabellar lines located between the eyebrows in the United States, Canada, and Europe. Subjects were either toxin-naïve or previously treated with neurotoxins and were evaluated over 12 weeks with up to two treatments of BoNT/E.
The primary endpoints of both pivotal Phase 3 studies demonstrated statistical significance for improvement with BoNT/E versus placebo in glabellar line severity on the Facial Wrinkle Scale (FWS) from baseline at day 7 (based on both subject and investigator assessments). All tested secondary endpoints, including patient-reported outcomes on overall treatment satisfaction, demonstrated statistical significance, favoring improvement with BoNT/E versus placebo.
The onset of efficacy (i.e., at least 2-grade FWS improvement from baseline) was demonstrated at 8 hours after drug administration (the earliest assessment time) and efficacy duration was observed for 2-3 weeks after drug administration.
Treatment-emergent adverse events for BoNT/E were similar to placebo, both as a single treatment and up to two consecutive treatments.
"New patients considering facial aesthetic treatments may prefer a shorter-acting toxin with quick onset for their first treatment," says Cheryl Burgess, MD, FAAD, lead clinical investigator for one of the Phase 3 studies, in a news release. "Treatment with a product differentiated by a rapid onset of effect and short duration of action could offer these patients a different option compared to currently available neurotoxins, and I see the potential for BoNT/E to help grow the toxin experience for the new patient population in my practice."
Additional study results will be submitted for presentation at future medical meetings. A Phase 3 open-label safety study is ongoing, with results expected later this year.
"BoNT/E is a first-in-class, short-acting neurotoxin in development, and these results demonstrate its potential to bring true innovation to the aesthetics industry," adds Darin Messina, Ph.D., senior vice president, aesthetics R&D, AbbVie. "We are very pleased by these results, which provide strong evidence in support of BoNT/E's clinical profile and highlight significant progress within our next-generation toxin pipeline program."