SHINE-1 Results Suggest EB-001A May Improve Appearance of Scars
Bonti, a privately-held, clinical-stage biotechnology company, today announced the topline results of its SHINE-1 Phase 2a clinical trial, the first clinical trial in its SHINE (Scar Healing Improvement with Neurotoxin E) clinical program, aimed at scar reduction. SHINE-1 evaluated EB-001A, Bonti’s aesthetic product candidate, for scar reduction following Mohs surgery. This pilot trial achieved its objectives in showing a favorable safety profile and suggesting promising clinical efficacy. The trial also provided valuable insights into the scar assessment scales, that will guide selection of outcomes in future trials.
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. Considering the potential advantages of this profile, Bonti continues developing products to pursue targeted aesthetic and therapeutic indications, with its product candidates EB-001A and EB-001T, respectively, in areas of unmet needs with significant addressable market opportunities.
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.
- 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% better in appearance compared to scars in placebo subjects
- Subjects Reported Less Itching: At 24 hours post-surgery, none of the EB-001A treated subjects reported itching, compared to 75% of placebo subjects who reported itching in the same timeframe, based on Scar Cosmesis Assessment and Rating (SCAR) scores
- Subjects Reported 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
SHINE-1 was a randomized, placebo-controlled, double-blind (subject and investigator), parallel arm pilot trial designed to evaluate the safety and efficacy of EB-001A injections in patients undergoing Mohs micrographic surgery on the forehead. The SHINE-1 study evaluated a single immediate post-operative treatment of EB-001A intramuscular injections into the forehead, in a standardized injection paradigm.
“The SHINE-1 study results suggest that EB-001A has the potential to expedite the healing process and help physicians repair and improve outcomes of ‘cosmetically sensitive’ wounds” said Fauad Hasan, CEO and co-founder at Bonti. “Additionally, we are buoyed by the enthusiasm from facial aesthetics thought leaders who previewed the data. This trial supports the vision to make our faster-acting neurotoxin, EB-001A, a valuable addition to physicians’ aesthetic toolbox to enhance patient care and to better address patient unmet needs not captured by current marketed products.”
“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,” commented 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.
Bonti is developing a first-in-class pipeline of proprietary product candidates based on EB-001, which is derived from botulinum neurotoxin serotype E (BoNT/E). BoNT/E has a validated mechanism of action similar to that of currently approved products derived from BoNT/A, but, based on preclinical and clinical data, BoNT/E has a faster onset of action (within 24 hours) and a shorter duration of activity (2 to 4 weeks) compared to BoNT/A products, which have an onset of action of approximately 3 to 7 days and a duration of activity of approximately 3 to 4 months. Based on this differentiated clinical profile, Bonti’s aesthetic product candidate, EB-001A, is being initially developed for glabellar frown lines and for scar reduction following Mohs surgery and Bonti’s therapeutic product candidate, EB-001T, is being developed for the treatment of focal muscle pain.
Bonti, based in Newport Beach, CA, is an innovative clinical-stage biotechnology company focused on the development and commercialization of novel, fast-acting neurotoxin products for aesthetic and therapeutic applications. The company was founded and is led by executives with extensive experience obtained at Allergan plc with botulinum neurotoxin products from discovery, clinical, supply chain, regulatory and commercialization perspectives. By turning the science of neurotoxins into beneficial patient and healthcare provider solutions, Bonti seeks to improve lives by successfully addressing key unmet needs in markets with significant addressable opportunities.
For more information, please visit http://bonti.com.