Privately-held biotech Bonti said today that it launched the Lantern clinical program, evaluating its intramuscular neurotoxin injection as a non-opioid pain reliever.
The first clinical trial, Lantern-1, is a Phase II study designed to assess the safety and efficacy of EB-001 in patients undergoing elective breast augmentation.
The botulinum neurotoxin is characterized by a fast onset of action, about 24 hours, and a 4-week duration of effect, according to Bonti.
The Newport Beach, Calif.-based company said that the study will include a single, intra-operative administration of EB-001 into the patient’s pectoralis major. The primary outcome measure is the patient’s assessment of pain using a numeric pain-rating scale.
“We are excited about the commencement of our Lantern clinical program. As a locally administered biologic, EB-001 has the potential to address pain without the addiction risks or the side effects of current analgesic treatments,” co-founder & CEO Fauad Hasan said in prepared remarks. “The start of this Phase II study is a significant milestone toward successfully establishing EB-001 as a long-acting, non-opioid solution for the treatment of focal musculoskeletal pain. Our aim is to make EB-001 available as quickly as possible to help address the opioid epidemic affecting millions in the U.S. annually.”
Bonti said it expects results from the Phase II study by the end of this year.
“EB-001 has the potential to be one of the most meaningful pain management advances in decades for post-surgical and non-surgical care where opioids have long been the standard of care because of their efficacy, despite their side effects and risks,” Bonti advisor Dr. Valerie Lemaine added. “As a surgeon, I seek to provide my patients the best outcomes possible so they recover as rapidly and comfortably as possible and EB-001 has the promise to help me achieve this goal while helping stem the crisis we currently face with opioids. EB-001’s fast onset and short duration target profile will make a promising addition to our multi-modal pain relief options for pain management following breast surgeries.”