SASKATOON, Saskatchewan--(BUSINESS WIRE)--ZYUS Life Sciences Corporation ("ZYUS" or the “Company”) (TSX-V: ZYUS), a Canadian-based life sciences company leading scientific research and global development of innovative cannabinoid-based pharmaceutical drug products, is pleased to announce receipt of the final clinical study report and positive results respecting its Phase 1, first-in-human (“FIH”) Clinical Trial for its lead drug product candidate, Trichomylin® softgels.
About Trichomylin Softgels
Trichomylin softgels, a first-in-class drug product candidate formulated with a proprietary fixed-dose combination, has been specifically designed for the management of chronic pain. Its unique mechanism of action targets the endocannabinoid system distinguishing it from current pain management therapies, offering a novel approach in addressing chronic pain by delivering a balanced ratio of three cannabinoids - cannabidiol (“CBD”), cannabichromene (“CBC”) and delta-9-tetrahydrocannabinol (“THC”).
About the Trial
Study Z-TRI-10001 (NCT04867057), conducted through ZYUS’ wholly-owned subsidiaries, ZYUS Life Sciences Inc. and ZYUS Life Sciences Australia Pty. Ltd., was a Phase 1, FIH, randomized, double-blind, placebo-controlled, single and multiple ascending dose study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and food effect of Trichomylin softgels in healthy adult participants. A total of 41 healthy adult participants were enrolled in this study, with 31 participants in the active arm and 10 participants in the placebo arm. The Clinical Trial results confirmed that Trichomylin softgels were well tolerated and had a favorable safety profile, with no Serious Adverse Events (“SAEs”), no dose-limiting toxicities, and no trial suspension reported. Further, there was no indication of neurocognitive impairment, altered state of consciousness and no detrimental impact on overall well-being in participants based on the standard validated questionnaires. The Clinical Trial achieved a high rate of participant retention, with 97.5% of the enrolled participants completing the study, showcasing the feasibility, subject acceptability and engagement, and high quality of the study. The most commonly reported Treatment Emergent Adverse Events (“TEAEs”) were Euphoric Mood, Somnolence, and Fatigue, all of which were also reported with the placebo. The effect of food on the safety and tolerability of Trichomylin softgels was also assessed at a single dose level, showing no apparent effect on the safety profile of Trichomylin softgels. The evaluation of preliminary efficacy of Trichomylin softgels in adult patients with moderate to severe chronic osteoarthritis pain will be completed in a separate Clinical Trial.
Key highlights respecting Trichomylin softgels and the Phase 1 Clinical Trial include:
- Safety and Tolerability: Trichomylin softgels exhibited favourable safety and tolerability profiles, with no SAEs, no dose-limiting toxicities, and no trial suspension reported.
- Unique Mechanism of Action: Trichomylin softgels target the endocannabinoid system, a unique mechanism of action that sets it apart from conventional pain management therapies.
- Patient Retention: The trial achieved a high rate of participant retention, with 97.5% of the enrolled participants completing the study, showcasing the feasibility, subject acceptability and engagement and high quality of the study.
- Patent Protection: The Trichomylin softgels formulation has received patent protection in Canada, Australia, Israel, India, Korea, and South Africa. Additionally, patent applications have been filed in the U.S. and European Union, underlining the uniqueness and innovation of this novel fixed-dose combination developed to alleviate chronic pain.
"The outcome of our Phase 1 Clinical Trial is extremely promising and exemplifies our commitment to innovation, bringing us one step closer to providing patients with an approved pharmaceutical drug as an alternative to conventional pain management therapies," said Brent Zettl, President and Chief Executive Officer of the Company. "In less than five years, we have advanced from the initial phases of conceptualizing and refining the formulation to the successful completion of the Phase 1 Clinical Trial for Trichomylin softgels. This swift advancement is a testament to our deep expertise and unwavering commitment to delivering first-in-class and best-in-class drugs to patients worldwide."
Positive Phase 1 results and supportive pre-clinical data will assist ZYUS in its ongoing Phase 2 clinical development of Trichomylin softgels and further strengthens ZYUS’ commitment to secure regulatory approvals and ultimately bring this innovative therapy to patients suffering from chronic pain.
About ZYUS Life Sciences Corporation
ZYUS is a publicly traded Canadian-based life sciences company focused on the global development and commercialization of regulated cannabinoid-based pharmaceutical drug product candidates. Through clinical research, ZYUS is committed to furthering the understanding of cannabinoids with the clinical development of its pharmaceutical drug product candidates and intellectual property activities to protect its novel formulations. Additionally, ZYUS is dedicated to delivering high quality, cGMP/EU GMP-compliant cannabinoid products to patients through the exempt global medical market. The ZYUS vision is to reimagine the potential of pain therapeutics by pursuing regulatory approval of cannabinoid formulations and elevating cannabinoids as a standard of care in pursuit of transformational impact on patients’ lives. ZYUS: Advancing the Science of Well-Being. For additional information, visit www.zyus.com or follow us on X (formerly known as Twitter) @ZYUSCorp.
Cautionary Note Regarding Forward-Looking Statements
This news release contains “forward-looking information” within the meaning of applicable securities laws relating to the Company’s business, the Company’s ability to advance clinical research activities and further operations, realize on its objectives and obtain regulatory approval of cannabinoid-based pharmaceutical drug product candidates, introduce products that act as alternatives to current pain management therapies and advance Phase 2 clinical development of Trichomylin softgels. Any such forward-looking statements may be identified by words such as “expects”, “anticipates”, “intends”, “contemplates”, “believes”, “projects”, “plans” and similar expressions. Readers are cautioned not to place undue reliance on forward-looking statements. Statements about, among other things, the Company’s business, the Company’s ability to advance clinical research activities and further operations, realize on its objectives and obtain regulatory approval of cannabinoid-based pharmaceutical drug product candidates, introduce products that act as alternatives to current pain management therapies and advance Phase 2 clinical development of Trichomylin softgels are all forward-looking information. These statements should not be read as guarantees of future performance or results. Such statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from those implied by such statements. Although such statements are based on management’s reasonable assumptions, there can be no assurance that the Company will be able to advance its clinical research activities and further operations, realize its objectives and obtain regulatory approval of cannabinoid-based pharmaceutical drug product candidates, introduce products that act as alternatives to current pain management therapies or advance Phase 2 clinical development of Trichomylin softgels. The Company assumes no responsibility to update or revise forward-looking information to reflect new events or circumstances or actual results unless required by applicable law. Neither the TSXV nor its Regulation Services Provider (as that term is defined in the policies of the TSXV) accepts responsibility for the adequacy or accuracy of this press release.