The company’s lead product candidate is EB-001, a botulinum neurotoxin serotype E (BoNT/E). EB-001 has a validated mechanism of action similar to that of botulinum neurotoxin serotype A (BoNT/A), e.g. BOTOX®, but with a differentiated clinical profile. Specifically, compared to BoNT/A, EB-001 has fast onset of action, 1 day versus 3-7 days, and short duration of effect, 1 month versus 3-4 months. EB-001 is well suited to address a greater than $7B market opportunity with 19M surgical and non-surgical procedures annually, where the treatment of the root cause of painful focal skeletal muscle spasms can improve outcomes and reduce morbidity.
CURRENT PHASE 2 STUDY
The first-in-human (FIH) trial, which is designated as Phase 2 by FDA’s Division of Dermatology, is being conducted in a glabellar frown lines (GL) model to establish safety and clinical proof of concept (PoC) for EB-001. The clinical data from this study will also be used to establish dosing for Phase 2 therapeutic indication studies in two pain models in Q3 2017. Further Bonti will use the Phase 2 clinical data in the GL model as basis for partnering discussions with other companies that are focusing in the aesthetic and/or pain space. Interim data was presented at the end of April 2017.