Zelira Therapeutics, a global leader in the research, development and commercialization of clinically validated cannabinoid medicines, is about to begin a first-ever clinical trial of its own proprietary pain formula for the treatment of diabetic nerve pain against an as-yet-unidentified brand name pain medication, the company announced. (Benzinga)
The trial will evaluate the efficacy, safety and tolerability of Zelira’s patent-protected product.
How is the trial set up?
The trial is designed as a multi-arm, head-to-head comparison of 60 subjects, with 20 subjects in each arm, powered to show statistical difference. A total of 20 patients in the investigative drug arm have already been enrolled.
“This product trial exemplifies Zelira’s strategy to continue generating clinical validation for cannabinoid-based medicines,” said Dr. Oludare Odumosu, CEO of Zelira Therapeutics.
“We look forward to what we hope will be positive results in this clinical trial and continue to deliver on our ‘multiple shots on goal’ strategy for both our OTC products and our RX prescription cannabinoid products worldwide.”
Partnering with Pennsylvania Global Contract Research Organization (CRO), Affinity Bio Partners to manage the clinical trial, Zelira said they expect results by the end of 2022.
What else is Zelira doing?
Zelira is focused on developing branded cannabinoid-based medicines for the treatment of a variety of medical conditions, including insomnia, autism and chronic non-cancer pain with the goal of providing solutions to patients who are no longer receiving a benefit from their conventional treatments.
The company owns a portfolio of proprietary revenue-generating products and a pipeline of candidates undergoing clinical development that are positioned to enter global markets.
Two of the company’s proprietary formulations under the HOPE brand are generating revenues in Australia and Pennsylvania. They have been licensed in Louisiana and Washington D.C., with other US states expected to follow.
Zelira is also generating revenue in Australia from its proprietary and patented Zenivol, a leading cannabinoid-based medicine for the treatment of chronic insomnia. Zenivol has successfully completed the world’s first Phase 1b clinical trial for chronic insomnia where it was found to be a safe and effective treatment.