Phase 1a/1b clinical trials beginning April 2021 will assess the safety and tolerability of ZYUS’ lead drug product candidate in healthy adult participants
ZYUS Life Sciences Inc. (“ZYUS”), a Canadian life sciences company leading scientific research and development in phyto-therapeutics, announced today that it will be launching a first-in-human (FIH) clinical trial on the safety, tolerability and efficacy of its lead drug product candidate, Trichomylin®, through its wholly owned subsidiary, ZYUS Life Sciences Australia Pty. Ltd. The formulation being studied is a proprietary novel fixed-dose cannabinoid formulation developed by ZYUS to alleviate chronic pain. The HOPE (Human Osteoarthritis Pain Evaluation) clinical trial will begin in Australia, April 2021.
The clinical trial, which will be registered on clinicaltrials.gov, will determine the safety of single and repeat doses of Trichomylin® and be conducted under Australia’s Therapeutic Goods Act, 1989 in strict accordance with the Declaration of Helsinki and the ICH Good Clinical Practices.
While the Phase 1a/1b will be conducted in Australia under the supervision of the Therapeutic Goods Administration, ZYUS also submitted a request for a pre-Investigational New Drug (“Pre-IND”) meeting with the U.S. Food and Drug Administration (FDA). The FDA has provided ZYUS with valuable feedback on its clinical trial plan for Trichomylin®, and offered guidance on how to pursue the 505(b)(1) regulatory pathway, which is a regulatory pathway available for novel formulations that have not been previously studied or approved. The 505(b)(1) drug development regulatory pathway would provide ZYUS with a rigorous framework within which it could conduct human studies on the safety and efficacy of Trichomylin®.
“ZYUS is committed to a science-based approach to clinical trials, which forms the foundation to design and develop formulations to alleviate chronic pain. We believe the results of our HOPE clinical trial will get us one step closer to providing patients with the relief they need,” said ZYUS CEO Brent Zettl. “These trials will focus on patient safety and it is our goal that this critical research leads to a solution that will greatly improve quality of life and well-being for the millions of people worldwide who suffer from chronic pain.”
The clinical research will be split into two phases: Phase 1a will evaluate drug safety and tolerability in healthy participants starting April 2021, with initial results expected by fall 2021. Phase 1b will evaluate the efficacy of Trichomylin® for pain management in a limited number of patients with osteoarthritis, with results expected late 2021. The outcome aims to demonstrate safety of Trichomylin® and enable ZYUS to proceed with future clinical trials. “The HOPE clinical trial underscores ZYUS’ commitment to the highest standards of patient centered research and builds trust with healthcare practitioners by leveraging data-driven science to advance the clinical understanding of cannabinoids and their role in pain management,” said Lionel Marks de Chabris, Chief Medical Officer at ZYUS. “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.”
Launching the HOPE clinical trial is another step in ZYUS’ mission to advance the science of well-being. In December 2020, ZYUS received Health Canada approval to directly distribute cannabinoid formulations to registered patients in Canada. Prospective patients or healthcare practitioners (HCPs) seeking more information on ZYUS or its products can visit ZYUS.ca or speak to a member of the ZYUS patient care team at 1-833-713-CARE (2273).