NEWPORT BEACH, Calif.--(BUSINESS WIRE)--Bonti, a privately-held, clinical-stage biotechnology company, today announced the debut presentation of interim clinical data from Phase 2 study EB-001-GL201 of EB-001 in subjects with glabellar (frown) lines. Dr. Steve Yoelin, a co-principal investigator of the study, led off the highly attended Premier Global Hot Topics session at The Aesthetic Meeting 2017, organized by the American Society of Aesthetic Plastic Surgery (ASAPS), on April 28th in San Diego, CA. EB-001 is a novel Type E botulinum neurotoxin with a unique clinical profile, characterized by fast onset of effect. EB-001 will target aesthetic and therapeutic indications with multi-billion dollar addressable market opportunities.
Dr. Yoelin, a world-renowned neurotoxin and facial aesthetics expert, is a co-principal investigator of the EB-001 Phase 2a clinical study (Study EB-001-GL-201). He highlighted the study design and previewed interim safety and efficacy data in his presentation. EB-001 is currently being evaluated in subjects with moderate to severe glabellar (frown) lines in a placebo-controlled, ascending dose cohort study which includes a single treatment cycle and follow-up for 28 days.
A total of 24 subjects in 4 cohorts have been treated to date (20 received active drug, 4 received placebo). Review of blinded data suggests EB-001 is safe and well-tolerated at the doses administered so far. In blinded cohorts 3 and 4, several subjects showed a two point decrease in severity of glabellar lines, using the facial wrinkle scale, according to investigator assessment of severity. The onset of response was within 24 hours of treatment. Dose escalation will continue in order to determine the maximum efficacious dose and its duration of effect. Final study results will allow dose selection for future studies, and will be submitted for publication.
“The Bonti team, including our clinical investigators, was delighted when we began seeing positive data from our ongoing study and we are thrilled to have shared interim findings with key members of the medical community for the first time,” remarked Fauad Hasan, co-founder and CEO of Bonti. “It was a privilege to have Dr. Yoelin speak on our behalf and we are thankful to the ASAPS for choosing EB-001 for the Hot Topics forum. As we previously announced, the results from this study will not only be important in addressing unmet needs in facial aesthetics in the future, they will also enable Bonti to advance its therapeutic development program to study EB-001 as a non-opioid solution for the treatment of musculoskeletal pain.”
“This is a significant step forward for Bonti and I foresee EB-001 being a valuable addition to our aesthetic toolbox,” remarked Dr. Jean Carruthers, a pioneer in the cosmetic use of Type A botulinum neurotoxin and currently a Bonti Medical Advisor. “I’m excited to see how rapidly this unique neurotoxin has progressed from the lab to the clinic. We’ve been waiting for this new option for a long time.”
About Dr. Steve Yoelin
Dr. Yoelin is a board-certified physician who currently practices in Newport Beach, CA and has been a thought leader in the clinical and research fields. For the past decade he has developed an unprecedented expertise in facial aesthetics including the use of neurotoxins, dermal fillers and collagen stimulators. Dr. Yoelin is focused on innovation and has served as lead investigator in several pilot studies for novel agents, including one that led to a first-in-class FDA approved aesthetic product. Dr. Yoelin has lectured extensively on the use of facial injectables at numerous educational events in the U.S. and at international conferences.
About Dr. Jean Carruthers
Dr. Carruthers is Clinical Professor of Ophthalmology at the University of British Columbia. With her dermatologist husband Dr. Alastair Carruthers, she pioneered the cosmetic use of Type A botulinum neurotoxins and their combined use with three dimensional fillers, energy based devices and cosmetic surgery. She has published 288 peer reviewed scientific papers, 69 textbook chapters and 9 textbooks on this area and continues a very active research department. She is Fellow of the Royal College of Surgeons in Canada, the Royal College of Ophthalmologists in the UK and Fellow of the American Society of Ophthalmic Plastic and Reconstructive Surgery. She has given more than 300 presentations worldwide on topics in cosmetic medicine and surgery. She has received several awards including in 2017 the highest honour of the American Society for Dermatologic Surgery, the Samuel J Stegman Award. Dr. Carruthers has been profiled in numerous publications including Best Doctors in Canada, the New York Times, Allure magazine, Time, Newsweek and Vogue. She has also been featured on the television program 20/20.
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 BoNT/A products though it has a differentiated clinical profile. EB-001 has a fast onset of action (about 24 hours) and short duration of effect (about 4 weeks). Currently marketed BoNT/A products have an onset of action around 3-7 days and a duration of effect around 3-4 months. The unique target clinical profile of EB-001 is 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. Study EB-001-GL-201, focusing on treatment of glabellar (frown) lines, is currently ongoing (Clinicaltrials.gov NCT02939326).
Bonti, based in Newport Beach, California, is a rapidly emerging biotechnology company founded by world class neurotoxin experts with proven success at Allergan, one of the Fortune 500 fastest growing pharma companies. This team, with unsurpassed neurotoxin, aesthetic and pain expertise, is uniquely qualified to develop unprecedented treatment paradigms driven by a novel neurotoxin platform 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 will improve lives by successfully addressing key unmet needs in markets with multi-billion dollar addressable opportunities.
For more information, please visit http://bonti.com.