Bonti has commenced dosing in its LANTERN-2 clinical trial, a Phase II study designed to evaluate the safety and efficacy of EB-001A for the treatment of patients with focal muscle pain.
LANTERN-2 is part of Bonti’s Long-Acting Neuro Toxin-E Relief, Non-opioid (LANTERN) clinical trial programme.
The trial includes patients undergoing elective abdominoplasty (tummy tuck) surgery.
Its dose selection phase is based on positive safety results from a recently completed LANTERN-1 clinical trial, the first of the LANTERN programme.
The trial includes a single intra-operative administration of EB-001T IM injection into the rectus abdominis (RA) muscle in the enrolled patients undergoing abdominoplasty with plication of the RA sheath.
Primary endpoint of the trial is reduction of post-operative pain at rest as measured by the Numeric Pain Rating Scale (NPRS) over the first 96 hours.
Its secondary endpoints feature NPRS during activity and patient use of rescue medications, including opioids, to address unrelieved pain.
Topline results from the trial are expected to be available in the fourth quarter of this year.
Bonti CEO and co-founder Fauad Hasan said: “EB-001T has the potential to be an effective locally acting pain treatment that addresses a root cause of pain by decreasing muscle hyperactivity and spasms following surgery and in non-surgical cases.
“EB-001T may help healthcare providers and patients reduce the use of opioids, with their associated side effects and risk of addiction. We continue to press ahead toward the objective of establishing EB-001T as a long-acting, non-opioid solution for the treatment of focal muscle pain.”
EB-001A is derived from botulinum neurotoxin serotype E (BoNT/E) and can have a differentiated clinical profile with a faster onset of efficacy and a shorter duration of activity than botulinum neurotoxin serotype A (BoNT/A) products.