- Phase 2a UTOPIA-1 trial results showed Trichomylin® softgel capsules demonstrated clinically relevant efficacy signals using multiple pain assessments.
- Trichomylin® softgel capsules were well-tolerated, with no related serious adverse events observed, supporting the sustainability of an individualized titration dosing regimen.
- Trichomylin® softgel capsules demonstrated opioid-reducing potential, identified as a key finding that warrants further investigation as a potential co-primary endpoint in future clinical trials. This aligns with the U.S. Food and Drug Administration (the "FDA") draft guidance (issued September 2025 and updated May 2026), which encourages pharmaceutical development programs that both expand novel analgesic options and decrease opioid analgesic exposure and prevent new addiction.
- Data supports advancement of Trichomylin® softgel capsules into larger randomized controlled trials to further evaluate safety, pain management efficacy, and opioid reduction.
SASKATOON, SK, Oct. 1, 2026 /PRNewswire/ -- ZYUS Life Sciences Corporation (the "Company" and or "ZYUS") (TSXV: ZYUS), a clinical-stage life sciences company focused on the development and commercialization of novel non-opioid drug candidates for pain management, today announced positive topline results from its Phase 2a UTOPIA-1 (Unique Treatment of Oncology Pain in Advanced Cancer) clinical trial evaluating dosing, safety, and efficacy of Trichomylin® softgel capsules in patients with advanced cancer experiencing moderate to severe cancer-related pain.
Phase 2a UTOPIA-1 Study Design
The recently completed Phase 2a UTOPIA-1 trial was conducted at three Canadian sites: McGill University Health Center, CancerCare Manitoba, and Centre Hospitalier de l'Université de Montreal. A total of 11 patients were enrolled (5 men, 6 women; mean age 60.7 years) and maintained on standard-of-care pain management, including long-acting opioids, throughout the trial. The study design used an individualized titration dosing design for Trichomylin® softgel capsules as additional pain management. The Phase 2a UTOPIA-1 trial design enabled the evaluation of key objectives, including dosing via individualized titration, safety and tolerability, pain management, quality of life, and opioid use.
Phase 2a UTOPIA-1 Topline Results
Based on internal analyses of data available as of the date of this announcement, the Phase 2a UTOPIA-1 trial fulfilled its role as a signal-generating study, achieving encouraging findings among key objectives.
Among the full set of 11 patients enrolled and treated with Trichomylin® softgel capsules:
- Dosing: 91% of patients successfully titrated to an individualized, stable dose level.
- Safety: No treatment-related serious adverse events were observed.
In the subset of 7 evaluable patients that adhered to the treatment and assessment plan:
- Pain analyses signaled a clinically relevant decrease in pain (a pre-defined ≥30% threshold for improvement) across multiple pain assessments at the end of Trichomylin® softgel capsules dosing:
- Average Pain: 43% of patients met the threshold for pain on average;
- Pain Severity: 29% of patients met the threshold for pain severity; and
- Pain Interference: 57% of patients met the threshold for pain interference.
- Changes in symptoms of pain, fatigue, and insomnia signaled health-related quality of life improvements.
- At the end of Trichomylin softgel capsule dosing, 29% of evaluable patients rated their overall condition as much improved, consistent with the pre-defined threshold for clinical relevance, while 57% rated their overall condition as minimally improved.
In a secondary analysis of opioid use, a signal of reduced rescue opioid use was observed during treatment with Trichomylin® softgel capsules. All patients in the evaluable subset were prescribed opioids for breakthrough pain:
- Rescue Opioid Use: 7 of 7 patients were prescribed rescue opioid medications.
- Rescue Opioid Use: 2 of 7 patients did not require use of their rescue opioids during dosing of Trichomylin® softgel capsules.
- Rescue Opioid Reduction: Of the 5 of 7 patients that used rescue opioids, the distribution of average rescue opioid use across Trichomylin® softgel capsules dosing phases revealed that approximately 79% occurred in the titration phase, which then decreased to approximately 6% during stable dosing of Trichomylin® softgel capsules.
Visit ZYUS.com to view the full Phase 2a UTOPIA-1 Summary Report.
"Trichomylin® softgel capsules are positioned between NSAIDs, which are often insufficient for moderate-to-severe pain, and opioids, which are effective but carry risks of dependency and abuse," said Scott Livingstone, Vice President, Clinical Operations of ZYUS. "The Phase 2a UTOPIA-1 trial is an important step in generating the clinical evidence to support the continued development of Trichomylin® softgel capsules as a potential non-opioid treatment option."
"These Phase 2a UTOPIA-1 results are an encouraging step toward understanding how Trichomylin® softgel capsules may complement standard of care for pain control," said Dr. Julie Stakiw, Chief Medical Officer of ZYUS. "Patients reported improvements beyond pain reduction, including fatigue and sleep, and these findings support advancing into long-term studies of safety, efficacy, and the potential for opioid reduction."
Next Steps
In addition to positive signals for efficacy, safety, and opioid reduction, the Phase 2a UTOPIA-1 trial generated important scientific and operational insights to inform the potential advancement of Trichomylin® softgel capsules into future controlled clinical trials. Final interpretation of the results and planning for the next clinical trial will be informed by validated analyses of the programmed dataset, which are currently in progress. The Company plans to incorporate opioid-reduction, for both long-acting and breakthrough opioids, as a co-primary endpoint alongside pain efficacy in future trials. This objective is intended to align with the FDA's draft guidance, Development of Non-Opioid Analgesics for Chronic Pain, released September 2025 (updated May 2026).
The Company plans to present topline results from its Phase 2a UTOPIA-1 trial at the Montreal International Palliative Care Congress ("MIPCC 2026") in October 2026, as well as at future scientific meetings. ZYUS also aims to submit the results for publication in a peer-reviewed journal.
"The opioid crisis has underscored the need for additional alternative treatment options for patients living with chronic pain. These Phase 2a UTOPIA-1 results represent an important milestone in the continued clinical and regulatory development of our lead drug candidate," said Brent Zettl, President and Chief Executive Officer of ZYUS. "We are sincerely grateful to the patients who chose to participate in this trial. While facing advanced cancer and the challenges associated with their illness, their willingness to contribute to clinical research has helped advance our understanding of potential new treatment options for patients living with cancer-related pain."
About Trichomylin® Softgel Capsules
- Patented fixed-dose combination formulation containing Cannabichromene ("CBC"), a new chemical entity protected by an issued Company patent.
- Demonstrated preclinical analgesic activity in neuropathic and inflammatory pain models comparable to or exceeding that of standard-of-care pain medications.
- Multiple mechanisms of action across voltage-gated sodium channels, anti-inflammatory pathways, and the endocannabinoid system, aim to provide broad and robust therapeutic pain management effects.
- Favourable safety profile expected to be compatible with patients taking opioids, enabling the potential for opioid-reduction.
For more information about the design of the Phase 2a UTOPIA-1 trial, please visit clinicaltrials.gov and reference identifier NCT06533657.
About ZYUS Life Sciences Corporation
ZYUS (TSXV: ZYUS) is a clinical-stage life sciences company advancing a pipeline of novel, non-opioid pharmaceutical drug candidates targeting a significant unmet need in the global pain management market. Through rigorous scientific research and clinical development, ZYUS is building a robust intellectual property portfolio to protect its innovative therapies and strengthen long-term shareholder value. The Company is focused on advancing its proprietary drug candidates through clinical development and toward regulatory approval, with the goal of providing non-opioid treatment options for patients with chronic and neuropathic pain. For additional information, visit www.zyus.com follow us on X @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, obtain regulatory approval of non-opioid pharmaceutical drug candidates and introduce products that serve as alternatives to current pain management therapies such as opioids, the possibility of progression of the Phase 2a UTOPIA-1 trial to later stage trials, the potential use of Trichomylin® softgel capsules for pain management or as an alternative to other pain management therapies such as opioids, the Company's ability to bring to market innovative therapies such as Trichomylin® softgel capsules for pain management, commercialization of innovative therapies such as Trichomylin® softgel capsules for pain management, the relevancy of results from the Phase 2a UTOPIA-1 trial, the relevancy of signals shown in the results of the Phase 2a UTOPIA-1 trial and their implications for future trials, and the Company's beliefs regarding potential shareholder value. Any such forward-looking statements may be identified by words such as "expects", "anticipates", "intends", "contemplates", "believes", "projects", "plans", "will" and similar expressions. Readers are cautioned not to place undue reliance on such forward-looking statements. 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, including but not limited to the risk that the Company's analysis of the Phase 2a UTOPIA-1 trial results lead to further clinical trials, drug development, or commercialization, the risk that the later stage trials will not be feasible or possible, and the risk that the Company will be unable to continue funding clinical trials or its operations. Although such statements are based on management's reasonable assumptions, there can be no assurance that the Company will be able to achieve these results. 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.
The disclosure in this news release has been approved by Brent Zettl, Chief Executive Officer and Director of the Company.
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.
View original content to download multimedia:https://www.prnewswire.com/news-releases/zyus-life-sciences-announces-positive-topline-results-from-phase-2a-utopia-1-trial-evaluating-novel-non-opioid-pain-drug-in-patients-with-advanced-cancer-302895948.html
SOURCE ZYUS Life Sciences Corporation
