US-based biotechnology firm Bonti has launched a Phase II clinical trial (LANTERN-1) of EB-001 to treat patients with musculoskeletal pain.
EB-001 is a serotype E botulinum neurotoxin (BoNT/E) being developed to deliver rapid onset of action in approximately 24 hours and short duration of effect of around four weeks.
The placebo-controlled, double-blind ascending dose cohort LANTERN-1 trial assesses the safety and efficacy of EB-001 intramuscular (IM) injections in patients undergoing elective augmentation mammoplasty.
The trial’s primary outcome measure is evaluation of pain using the numeric pain rating scale (NPRS).
In addition to this trial, the LANTERN clinical programme includes another Phase II trial (LANTERN-2) designed to evaluate patients undergoing abdominoplasty.
Bonti co-founder and CEO Fauad Hasan said: “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.
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“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 US annually.”
The dose selection for the LANTERN programme was based on the efficacious and safe doses of EB-001, determined in a prior proof-of-concept Phase IIa trial conducted for the treatment of glabellar (frown) lines.
It is expected that the interim clinical results from the LANTERN-1 Phase II study will be available by the end of this year.