Concentric Analgesics has reported positive topline results from its Phase Ib clinical trial of CA-008 for the treatment of post-surgical pain.
The randomised, dose-escalation trial included 40 patients undergoing bunionectomy with standard of care Mayo block, and examined the safety of CA-008 compared to a saline control.
It included five cohorts of eight patients each, with six patients receiving CA-008 at ascending doses and the remaining two receiving control.
Altogether 30 patients received CA-008 at around ten-fold dose range.
The trial’s primary endpoints included the safety and pharmacokinetics of CA-008, while its secondary endpoints were the effect on pain intensity out to two weeks post-surgery and others.
Results of the trial showed that CA-008 was well tolerated at all dose levels compared to the control group following surgery in bunionectomy patients.
Lotus Clinical Research chief scientific officer Neil Singla said: “The long-lasting duration of effect of a single intraoperative injection of CA-008, and the reductions in pain scores compared to control are remarkable, particularly as this Phase Ib trial was designed primarily for safety and not powered for efficacy.
“CA-008 showed a better pain response than the control group at nearly every time point in every dose group, a very convincing result.”
Concentric is planning to begin a Phase IIb efficacy study of CA-008 in bunionectomy within this year, with top-line data expected by the end of the year.
CA-008 is a water-soluble pro drug that converts into capsaicin, a naturally occurring molecule that gives chilli peppers their heat.
It can be administered via wide infiltration at the surgical site.