SASKATOON, Saskatchewan–(BUSINESS WIRE)–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).
About ZYUS Life Sciences Inc.
ZYUS is a Canadian-based life sciences company focused on the global development and commercialization of innovative cannabinoid-based therapeutics and product candidates. Through clinical research and IP development, we intend to deliver high-quality oils, softgels, topical creams and other cannabinoid-based therapeutics and product candidates to patients worldwide. The ZYUS vision is to elevate cannabinoids as a standard of care and expand the potential of protein-based formulations in pursuit of a transformational impact on patients’ lives. ZYUS: Advancing the Science of Well-Being. Visit www.zyus.com.
This news release contains forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of ZYUS to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. These forward-looking statements include, but are not limited to, expectations with respect to our business plans, product lines, research activities (including without limitation, the safety, efficacy and clinical progress of Trichomylin®, the expected timing of the commencement of Phase 1 and availability of clinical trial results and the ability to use data generated by the Australian study to pursue FDA approval) and the prospects for regulatory approval, commercializing or selling any product or drug candidates. Research and clinical trial programs are of an experimental nature and no particular results can be guaranteed due to a number of factors and risks.
Often, but not always, forward-looking statements can be identified by the use of words such as “expects,” “expected,” “expectation,” “anticipates,” “believes,” “intends,” “estimates,” “predicts,” “continues,” “potential,” “targeted,” “plans,” “possible” and similar expressions, or statements that events, conditions or results “will,” “may,” “could,” “would” or “should” occur or be achieved, or the negative of these terms or other comparable terminology. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified, including risks related to: potential impacts due to the COVID-19 pandemic such as delays in regulatory review, manufacturing and supply chain interruptions, access to clinical sites, enrollment, adverse effects on healthcare systems and disruption of the global economy the reliability of the results of studies relating to human safety and possible adverse effects resulting from the administration of the Company’s product candidates; the Company’s ability to secure regulatory approval for any investigational new drug applications it may submit to the U.S. Food and Drug Administration, the Company’s ability to manufacture clinical trial materials on the timelines anticipated; and the success of future product advancements, including the success of future clinical trials. Consequently, actual results may differ materially from those expressed or implied by such forward-looking statements and readers should not place undue reliance on the forward-looking statements and information contained in this press release.
Readers are cautioned that the foregoing list of factors is not exhaustive. The forward-looking statements contained in this news release are made as of the date of this release and, accordingly, are subject to change after such date. ZYUS does not assume any obligation to update or revise any forward-looking statements or information respecting the proposed research or results therefrom, whether written or oral, that may be made from time to time by us or on our behalf, except as required by applicable law.