Bonti has begun their SHINE (Scar Healing Improvement with Neurotoxin E) clinical program, aimed at scar reduction using its novel neurotoxin.
EB- 001 is a novel botulinum neurotoxin serotype E (BoNT/E) with a unique product profile, characterized by fast onset of action (within 24 hours) and a short duration of effect (about 4 weeks).
The first clinical study, SHINE-1, is a randomized, placebo-controlled, double-blind, parallel arm trial to evaluate the safety and efficacy of EB-001 injections in patients undergoing Mohs micrographic surgery on the forehead. This study will evaluate a single intra- operative treatment of EB-001 intramuscular injections into the forehead muscles underlying the surgical wound following the Mohs procedure. The primary efficacy outcome measures to evaluate wound healing improvement and scar formation reduction include a Visual Analog Scale (VAS) and a Scar Cosmesis Assessment and Rating (SCAR) scale.
The SHINE (Scar Healing Improvement with Neurotoxin E) clinical program’s main objective is to support Bonti’s strategy to expand EB-001’s potential aesthetic indications. This requires conducting multiple clinical trials, starting with a Phase 2 study such as SHINE-1 in the Mohs surgery model.
“The Mohs surgical model will serve as an excellent model for demonstrating proof-of-concept for our therapy because it is widely used on millions of patients in the United States annually and because it is representative of the face and neck scars which physicians and patients are eager to address,” says Fauad Hasan, CEO and co-founder at Bonti., in a news release. “The potential use of EB-001 for scar reduction is yet another way in which our differentiated botulinum neurotoxin may benefit patients and physicians alike.”