Bonti’s lead product candidate, EB- 001, passed muster in a Phase 2A study for the treatment of glabellar lines.
EB-001 is a novel serotype E botulinum neurotoxin with a unique efficacy profile, characterized by fast onset of action (about 24 hours) and short duration of effect (about 4 weeks). The novel neuromodulator is being developed for aesthetic and therapeutic indications.
In the study of 42 subjects, EB-001 demonstrated dose-dependent clinical activity and efficacy at multiple doses. At the high dose cohorts, a 2-point response (assessed by the investigator) was observed within 24 hours of injection. At the two high doses, a 2-point response was reported in 80 percent of EB- 001 subjects and in 14 percent of the placebo group. The duration of clinical effect was two to four weeks post-injection in the high dose groups, the study showed. The study enrolled toxin naïve adults with moderate to severe glabellar lines and each subject received a single treatment cycle comprising five injection sites in the forehead glabellar muscles.
“I believe that EB-001’s unique product profile differentiates it from, and ultimately complements, the botulinum neurotoxins currently on the market,” says Steve Yoelin, MD an ophthalmologist in Newport Beach, CA and one of the study’s principal investigators. “EB-001 will likely expand the aesthetic market because it appears well suited to treat both neurotoxin-naïve patients looking to sample neurotoxins using a short-duration variant such as EB-001 as well as current neurotoxin patients looking to supplement their treatments. EB-001 has the potential to improve all injectors' ability to obtain the very best outcomes for their respective patients.”
All doses evaluated in the study were well tolerated and there were no serious adverse events (SAEs), or discontinuations due to adverse events (AEs). The overall incidence of treatment-emergent AEs was 14 percent of EB-001 subjects, and included headache, sore throat and flu-like symptoms, and was zero in the placebo group. These were transient and mild or moderate in severity. There were no AEs related to local spread of toxin, e.g., no eyelid drooping, reported at any dose.
This study confirmed the efficacious dose range of EB-001 in the treatment of glabellar lines. Dosing data from this study will inform dose selection for future studies, including a Phase 2B glabellar lines study and Phase 2 studies supporting Bonti’s therapeutic program in the treatment of focal musculoskeletal pain.