Canada-based ZYUS Life Sciences Inc. – a leading life sciences firm carrying out scientific research and development in phyto-therapeutics has announced that it will be initiating a first-in-human clinical study on the tolerability, safety, and efficacy of its leading product candidate- Trichomylin®, through its subsidiary ZYUS Life Sciences Australia Pty. Ltd.
Notably, the formulation under study is a proprietary fixed-dose cannabinoid solution that has been developed by ZYUS to treat chronic pain. The proposed HOPE (Human Osteoarthritis Pain Evaluation) clinical study will be carried out in Australia in April 2021.
In addition to the above, the clinical trial is slated to be registered on clinicaltrials.gov and will showcase the safety of single and multiple doses of Trichomylin® and will be carried out under Australia’s Therapeutic Goods Act of 1989 under stringent regulations established under the ICH Good Clinical Practices and the Declaration of Helsinki.
According to reliable reports, while Phase 1a/1b will be directed in Australia under the supervision of the Therapeutic Goods Administration, the Canadian company has also submitted a plea for a pre-investigation new drug meeting with the U.S. FDA.
Seemingly, the FDA has provided insights on the clinical study plan for the new candidate and also extended guidance on how to carry on with the 505(b)(1) regulatory pathway which is available for formulations that have not earlier been approved or studied.
For the record, the 505(b)(1) drug development regulatory pathway will offer ZYDUS a rigorous framework under which it can carry out human trials related to the efficacy and safety of Trichomylin®.
Reportedly, the research will be divided into two phases: Phase 1a will study the drug tolerability and safety in healthy volunteers beginning April 2021, with initial results likely to be received by fall 2021. On the other hand, Phase 1b will monitor the efficacy of the candidate for pain management in few patients with osteoarthritis, with results to be released in the latter half of 2021.