Canadian company Zyus Life Sciences will hold a clinical trial assessing the effectiveness of a new cannabis medication on chronic pain, paying participants $2,120 to acknowledge their participation.
Zyus is a Saskatoon-based health sciences company that operates in Australia through local subsidiary Zyus Life Sciences Australia Pty. Ltd. Zyus Australia will be conducting its new medical cannabis and chronic pain trial in Adelaide. The trial focuses on the new cannabis medication Trichomylin and its effect on chronic pain.
The HOPE (Human Osteoarthritis Pain Evaluation) clinical trial will consist of two key phrases. First, Zyus Australia will test the safety and tolerability of Trichomylin on healthy subjects in Phase 1a. Phase 1A has already begun, with results expected in the coming months. Next, Zyus Australia will test the effectiveness of Trichomylin on people with chronic pain in Phase 1b. Results from Phase 1b are expected in late 2021.
The trial is a ‘first-in-human (FIH) trial, meaning this is the first time Trichomylin has been tested on human subjects. If successful, it will pave the way for Trichomylin to be brought to market for chronic pain patients. In Australia, an estimated 3.37 million people live with chronic pain.
According to Zyus’s Chief Medical Officer Lionel Marks de Chabris, the HOPE trial is part of the company’s science-based approach to medical cannabis.
The data from these studies will help lead the evidence-based use of cannabinoids and define a new era of hope for those struggling to manage their pain.
Before conducting the HOPE trial, Zyus consulted with several governing authorities, including Australia’s Therapeutic Goods Administration (TGA) and the United State’s Food and Drug Administration (FDA).
According to Zyus, the FDA has suggested 501(b)(1) as a potential regulatory pathway and a testing framework for Trichomylin. This pathway is designed for novel drug formulations that have not been previously studied or approved by the FDA.
The HOPE trial will be overseen by Australia’s TGA. If the trial shows Trichomylin can successfully help people manage their chronic pain, the company will pursue further clinical trials to test the drug.
If you’re interested in becoming a participant in the study, you can see more details and apply here.