US-based biotechnology company Bonti has started a Phase ll clinical trial of EB-001 in the treatment of reducing scars.
The ‘Scar Healing Improvement with Neurotoxin E’ (SHINE-1) trial primarily aims to examine the safety and efficacy of EB-001 injections in patients undergoing Mohs micrographic surgery on the forehead.
The randomised, placebo-controlled, double-blind, and parallel arm trial will examine a single intra-operative treatment of EB-001 intramuscular injections into the forehead muscles underlying the surgical wound using the Mohs procedure.
Primary efficacy outcome of the trial is to evaluate wound healing improvement and scar formation reduction including a visual analogue scale (VAS) and a scar cosmesis assessment and rating (SCAR) scale.
Bonti CEO and co-founder Fauad Hasan said: “As a key facet of developing novel treatment paradigms driven by our unique biologic platform, EB-001 has the potential to help physicians repair ‘cosmetically sensitive’ wounds leading to improved outcomes for patients.
“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.
“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.”
Last year, Bonti conducted a proof-of-concept Phase llA clinical study of EB-001 in the treatment of glabellar (frown) lines and was able to meet the study’s primary endpoint. Findings have confirmed dose selection for the SHINE-1 study.