Topline results from Bonti’s SHINE-1 Phase 2a clinical trial suggest that its novel neurotoxin is safe and likely effective for scar reduction following Mohs surgery.
EB-001, the active ingredient in EB-001A, is a novel botulinum neurotoxin serotype E (BoNT/E) with a unique clinical profile, characterized by a faster onset of action (within 24 hours) and a shorter duration of activity (2 to 4 weeks) compared to botulinum neurotoxin serotype A (BoNT/A) products.
In this trial, EB-001A or placebo was administered to the frontalis muscle immediately after Mohs surgery for skin lesions in the forehead in 12 subjects (8 active, 4 placebo) who were followed up to 90 days. EB-001A was well tolerated with no drug-related adverse events. EB-001A appeared to provide maximum benefit during the acute scar formation phase as the surgical wounds healed. Numerical improvements in clinical investigator-reported results and in key patient-reported outcomes suggest EB-001A may improve the wound healing process. The results include:
Improvement in Scar Appearance: Based on Visual Analog Scale (VAS) scores by the investigator on Day 30, EB-001A treated subjects showed scars which were about 50 percent better in appearance compared to scars in placebo subjects.
Less Itching: At 24 hours post-surgery, none of the EB-001A treated subjects reported itching, compared to 75 percent of placebo subjects who reported itching in the same timeframe, based on Scar Cosmesis Assessment and Rating (SCAR) scores.
Less Pain: At 24 hours and eight (8) days post-surgery, the majority of placebo subjects reported pain, while a smaller percentage of EB-001A treated subjects reported pain in the same timeframe, based on SCAR scores.
Improvement in Scar Characteristics: EB-001A treated subjects showed improvements in patient reported scar color and scar stiffness, as compared to the placebo group, based on Patient and Observer Scar Assessment Scale (POSAS) scores.
“This initial clinical trial establishes an encouraging foundation for future studies to confirm EB-001A’s potential benefits for patients concerned about scars following face and neck surgeries,” says Murad Alam, MD, Vice Chair, and Professor of Dermatology at Northwestern University’s Feinberg School of Medicine and a Mohs surgeon who led the SHINE-1 study. “The ability to potentially enhance patient outcomes and satisfaction following high-tension closure procedures is intriguing. This small proof-of-concept study suggests that EB-001A’s novel target profile, with fast onset and short duration, may decrease some of the unpleasantness patients endure during wound healing and likely lead to improved physical appearance of the eventual scar.”
SHINE Clinical Program
The SHINE (Scar Healing Improvement with Neurotoxin E) clinical program’s main objective is to support Bonti’s strategy to expand EB-001A’s potential aesthetic indications. This requires conducting multiple clinical trials, starting with the Phase 2a study, SHINE-1, in the Mohs surgery model.