EB-001 is a novel serotype E botulinum neurotoxin (BoNT/E) with a unique efficacy profile, characterized by fast onset of action (about 24 hours) and short duration of effect (about 4 weeks). EB-001 is being developed for aesthetic and therapeutic indications with significant addressable market opportunities.
The first-in-human (FIH) trial, which was designated as Phase 2 by FDA’s Division of Dermatology, for our lead product candidate, EB-001, was conducted in a glabellar frown lines (GL) model to establish safety and clinical proof of concept (PoC). The study achieved its objectives. We announced topline results of this Phase 2A study in August 2017 and confirmed favorable safety and a differentiated efficacy profile.
The results from this study are important in addressing significant unmet needs in facial aesthetics. They also enable us to move forward with our therapeutic development efforts to evaluate EB-001 as a long-acting, non-opioid solution for the treatment of focal musculoskeletal pain which will help address the opioid epidemic affecting millions in the U.S. annually. The clinical data from this study will be used to establish dosing for Phase 2 therapeutic indication studies in two pain models beginning in Q3 2017.