Zelira Therapeutics Ltd (ASX:ZLD, OTCQB:ZLDAF), which develops clinically validated cannabis medications, has secured ethics approval for a Phase 2a clinical trial to assess the effectiveness of its licensed patented cannabinoid formulation, ZTL-106, in treating patients with chronic pain.
Licensee Levin Health is sponsoring the trial at La Trobe University’s Sport and Exercise Medicine Research Centre (Melbourne, Australia) under an agreement struck in June 2021. Zelira will project manage the trial.
Phase 2a clinical trial
The Phase 2a clinical trial will study the efficacy of ZTL-106 in treating sports-related chronic pain experienced by retired professional and amateur athletes.
This randomised, double-blind, placebo-controlled clinical trial, conducted in collaboration with La Trobe University’s Sport and Exercise Medicine Research Centre, will investigate the use of ZTL-106 as an effective medicinal cannabis drug in treating the chronic pain that follows musculoskeletal injury.
World-renowned sports medicine expert Professor Peter Brukner will lead the trial.
With ethics now formally signed off by Bellberry Human Research Ethics Committee (HREC), the trial is expected to commence in April of the coming year, and to enrol 114 patients.
Future directions
The development positions Zelira as a leader in the design of medicinal cannabis products.
"We are thrilled that our world-class formulation and expertise in fast-tracking drug developments has been born out with the Bellberry ethics approval for this phase 2 clinical trial," Zelira Therapeutics managing director Dr Oludare Odumosu said.
“We look forward to continuing our partnership with Levin Health to validate a proprietary product that will help treat chronic pain," he added.
“To the best of our knowledge, this trial will be the first of its type globally in terms of evaluating the efficacy of medicinal cannabis in the treatment of chronic, non-cancer pain under strict controlled conditions,” Levin Health managing director Mark Brayshaw said.