Bonti Announces Dosing of the First Patient in the SHINE-1 Phase 2 Clinical Study Evaluating EB-001 for Scar Reduction
- Category: Proteins and Peptides
- Published on Thursday, 08 February 2018 17:18
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NEWPORT BEACH, CA, USA I February 8, 2018 I Bonti, a privately-held, clinical-stage biotechnology company, today announced the initiation of the SHINE (Scar Healing Improvement with Neurotoxin E) clinical program, aimed at scar reduction using its novel neurotoxin. 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. 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). Considering the potential advantages of this profile, Bonti continues developing products to pursue targeted aesthetic and therapeutic indications in areas of unmet needs with significant addressable market opportunities.
In a proof-of-concept Phase 2A clinical study in 2017, EB-001 met its primary endpoint in the treatment of glabellar (frown) lines and was well tolerated. Dose ranging results from that study confirmed dose selection for the SHINE-1 study. The SHINE-1 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.
“We are excited about the start of our SHINE scar reduction clinical program. 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,” said Fauad Hasan, CEO and co-founder at Bonti. “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.”
“EB-001 can potentially help me address scarring, one of my patients’ most significant concerns following face and neck surgery,” commented Murad Alam, MD, Vice Chair, and Professor of Dermatology at Northwestern University’s Feinberg School of Medicine and a Mohs surgeon. “I’m always thinking about how to improve patient outcomes and the overall patient experience so working with a tool such as EB-001 which may help me address these areas is exciting to consider. EB-001’s unique neurotoxin target profile, with a fast onset and short duration, may be ideal to help us achieve what’s best for patients aesthetically following Mohs and other surgeries.”
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-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.
Bonti’s lead product candidate, EB-001, is an investigational botulinum neurotoxin serotype E (BoNT/E). EB-001 has a mechanism of action similar to the marketed botulinum neurotoxin serotype A (BoNT/A) products though it has a differentiated clinical profile. EB-001 has a fast onset of action (within 24 hours) and a short duration of effect (about 4 weeks). Currently marketed BoNT/A products have an onset of action of 3 – 7 days and a duration of effect of 3 – 4 months. The unique target clinical profile of EB-001 may be well suited for a vast range of aesthetic and therapeutic uses, including for the treatment of post-surgical and non-surgical musculoskeletal pain, with currently unmet needs.
Bonti, based in Newport Beach, California, is a rapidly emerging biotechnology company founded by world class neurotoxin and biologics experts with proven prior success at Allergan and Halozyme. This team, with deep neurotoxin, aesthetic and pain expertise, is uniquely qualified to develop treatment paradigms driven by a novel neurotoxin platform designed to become an innovative leader in both aesthetic and therapeutic markets. By turning the science of neurotoxins into beneficial patient and healthcare provider solutions, Bonti seeks to improve lives by successfully addressing key unmet needs.