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.
The trial was conducted by Lotus Clinical Research at Huntington Memorial Hospital in Pasadena, California, US.
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.