SASKATOON, Saskatchewan– 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.
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”).
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.
“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.
