Could a botulinum neurotoxin be a game changer to opioids for treating pain?
The novel serotype E botulinum neurotoxin EB-001 for treating focal musculoskeletal pain is the lead product candidate of biotech company Bonti Inc. (Newport Beach, Calif.).
“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,” says Fauad Hasan, president, CEO and co-founder of Bonti.
Hasan notes that EB-001 has a fast 24-hour onset of action and a short 3- to 4-week duration of effect. This is in contrast to currently marketed BoNT/A products, “which have an onset of action around 3 to 7 days and a duration of effect about 3 to 4 months,” he says.
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 postsurgical and nonsurgical musculoskeletal pain, with currently unmet needs,” Hasan tells The Aesthetic Channel.
Focal musculoskeletal pain is a root cause of postsurgical and of nonsurgical pain. “EB-001 can address muscle spasms and hyperactivity incurred by surgery or in nonsurgical conditions because it prevents the release of acetylcholine at the neuromuscular junction, thereby temporarily inhibiting spasms,” Hasan explains. “By hindering spasms, EB-001 attacks the source of the pain.”
Conversely, opioids and other pain relief drugs “work by blocking the sensory nerve signals sent to the brain, not the spasm that is initiating the pain,” Hasan says.
The first clinical study of EB-001, LANTERN-1, is a placebo-controlled, double-blind ascending dose cohort trial to evaluate the safety and efficacy of intramuscular (IM) injections in patients undergoing elective augmentation mammoplasty.
The treatment protocol is a single intraoperative treatment of EB-001 IM injections into the pectoralis major.
The primary outcome measure is the patient’s assessment of pain using the Numeric Pain Rating Scale (NPRS). Interim clinical results from the LANTERN-1 Phase 2 study are expected by year-end 2017, and the company expects the product to reach market within about 4 years.
“EB-001 may be a significant addition to physicians’ postsurgical and nonsurgical condition multimodal pain management options to treat pain effectively, while reducing the use of opioids to help address the opioid epidemic,” Hasan says.