Zelira Therapeutics (ASX:ZLD) (OTCMKTS:ZALDF) has secured Institutional Review Board (IRB) approval for a pain observational trial to take place in the US.
The cannabinoid medicines developer is set to test its patent-protected product against a big pharmaceutical company’s multi-billion-dollar revenue drug.
Approval from IRB means Zelira has navigated a regulatory approval path for the upcoming trial, with the first batch of results expected in 2022’s first half.
Ultimately, it’s hoped the trial will measure how effectively Zelira’s offering can treat neuropathic pain compared to a major, established pharmaceutical drug.
Zelira to conduct “innovative trial”
Zelira Therapeutics Chairman Osagie Imasogie said: “We are very pleased with receiving our IRB approval.
“We are even more pleased that we can conduct this innovative trial that we hope will provide additional safe and effective options for physicians and patients in the treatment of pain caused by neuropathy.”
The observational study
With IRB approval in tow, Zelira will trial its patent-protected product during a US-based observational study, which is poised to run for 12 weeks.
Specifically, the healthcare stock will evaluate the efficacy, safety and tolerability of its proprietary creation compared to a major drug from a big pharmaceutical company.
While the specific company is not named in today’s release, big pharma is defined as a suite of multinational, highly successful pharmaceutical operations with economic, political or social influence.
It means Zelira is set to go head-to-head with a major recognised pharmaceutical body in the upcoming trial.
Zelira partners with Levin
Today’s news comes just weeks after Zelira licensed its cannabinoid formulation to Levin Health Limited for an upcoming clinical trial.
During the study, Levin will use the medicinal cannabis company's ZTL-106 formulation for testing on retired athletes in a chronic pain treatment study at La Trobe University in Melbourne.
This trial will be sponsored by Levin, which will pay Zelira to design and manage the study, while both companies will share any commercialisation profits.
At the time, Zelira Therapeutics managing director Dr Oludare Odumosu said: “Zelira is thrilled to partner with Levin Health on this innovative drug development project.
“This collaboration demonstrates Zelira’s world-class formulation and expertise in fast-tracking drug development.
“This partnership also leverages Levin Health’s mission to impact chronic pain treatment approaches.
"We look forward to creating and validating a proprietary product that will help treat chronic pain.”