Concentric Analgesics has commenced a Phase ll clinical study of CA-008 for the treatment of post-surgical pain.
As part of the randomised, double-blind, placebo-controlled, dose-ranging trial, an undisclosed number of patients undergoing bunionectomy will be enrolled.
The trial’s primary objective is to examine the efficacy and safety of a single dose of CA-008 at different doses against placebo.
Findings from the trial are expected to allow Concentric to determine the precise dose of CA-008 for future clinical studies.
Concentric Analgesics chief medical officer Mike Royal said: “Our first-in-human Phase lb (Plb) bunionectomy study demonstrated that CA-008 can be administered safely to surgical patients, and the strong signal of efficacy supports its unique and compelling therapeutic profile.
“CA-008 has the potential to dramatically improve patient recovery and outcomes by providing long-lasting pain relief during the immediate post-operative period and throughout outpatient recovery.
“Initiating a larger Phase ll study is the next step in advancing our clinical development programme to bring CA-008 to market.”
The newly concluded, Phase lb placebo-controlled trial showed safety and tolerability of CA-008 across the study doses in patients undergoing bunionectomy.
CA-008 also demonstrated a statistically significant and clinically meaningful 63% reduction of pain intensity for area under the curve (AUC) at 0h-168h, as well as statistically significant reductions of pain at 48h, 72h, 96h and 120h, and nearly a 50% reduction in opioid consumption.
CA-008 is an investigational water-soluble non-opioid prodrug that can be rapidly converted to capsaicin, a potent TRPV1-agonist which selectively desensitises pain conducting nerve fibres to provide long-lasting analgesia.