Rhelion Life Sciences' Wholly Owned Subsidiary Filament Health Delivers PEX010 to Bruyere Health Research Institute's Phase 3 Trial of Microdose Psilocybin in Palliative Care
Supplying PEX010 for a 120-patient Phase 3 palliative-care trial expands Rhelion’s clinical footprint in natural psilocybin therapies.
Rhea-AI Summary
Rhelion Life Sciences (TRUFF), through wholly owned subsidiary Filament Health, has shipped its patented psilocybin drug candidate PEX010 to Bruyère Health Research Institute for a Phase 3, multi‑site, double‑blind, placebo‑controlled trial in palliative care.
The PSYCHED‑PAL study will compare microdose psilocybin with placebo in 120 people with advanced illness and psychological distress, recruited from inpatient, outpatient and community palliative care settings across seven Canadian sites. Participants will take small daily, non‑hallucinogenic doses that do not require accompanying psychotherapy, aimed at being practical for end‑of‑life care. Bruyère Health Research Institute sponsors the trial; Filament is not responsible for its conduct.
The Phase 3 trial builds on a Phase I/II study using PEX010 that reported microdose psilocybin as safe, feasible and potentially effective, with no serious adverse effects. PEX010 is supplied in standardized 1, 5 and 25 mg doses, with 0.5 mg to follow, and supports more than 80 research studies worldwide. Rhelion completed its acquisition of Filament and its 77‑patent portfolio on April 30, 2026.
Positive
- PEX010 supplied to Phase 3 palliative-care trial enrolling 120 participants
- Trial spans 7 Canadian sites, broadening clinical evaluation of PEX010
- Prior PSYCHED-PAL study reported no serious adverse effects with PEX010
- PEX010 supports more than 80 academic and philanthropic research studies
- Filament holds 77 issued patents across 13 patent families
- Rhelion completed acquisition of Filament and lead asset PEX010 on April 30, 2026
Negative
- None.
AI-generated analysis. How Rhea-AI works. Not financial advice.
- Filament has shipped PEX010 to Bruyère Health Research Institute for its Phase 3 placebo-controlled trial, which follows a published Phase I/II study that found microdose psilocybin safe, feasible and potentially effective for psychological distress in people with advanced illness.
Toronto, Ontario--(Newsfile Corp. - September 21, 2026) - Rhelion Life Sciences Corp. (CSE: RHEL) (FSE: 4YX) (OTCQB: TRUFF) ("Rhelion" or the "Company") an Ontario-based organization advancing innovation and research within the legal psychedelic sector. Through its wholly owned subsidiary Filament Health Corp. ("Filament"), the Company develops, manufactures and supplies PEX010, its patented, standardized, GMP manufactured botanical psilocybin drug candidate, to clinical research and compassionate access programs at leading institutions worldwide.
The Company is pleased to announce that Bruyère Health Research Institute ("BHRI") in Ottawa has received a shipment of PEX010 from Filament for the Phase 3 trial titled "Psilocybin Microdose for Psychological and Existential Distress in Palliative Care (PSYCHED-PAL): A Multi-Site Phase 3 Double-Blind, Placebo-Controlled, Parallel-Arm Clinical Trial" (NCT07063862).
The trial will compare microdose psilocybin with placebo in people with advanced illness who are experiencing psychological distress, such as depression, anxiety and loss of meaning. It plans to enrol 120 participants from inpatient, outpatient and community palliative care settings across seven sites in Canada. Participants take small daily doses that do not cause hallucinations and do not require accompanying psychotherapy, an approach designed to be practical for patients near the end of life. Bruyère Health Research Institute is the sponsor of the trial. Filament is not the sponsor of the trial and is not responsible for its conduct.
The Phase 3 trial builds on the Phase I/II PSYCHED-PAL study (NCT04754061), sponsored by The Ottawa Hospital Research Institute, which also used PEX010. Results published in Palliative Medicine in 2026 found that microdose psilocybin was safe, feasible and potentially effective for psychological distress in a palliative setting, with participants reporting improvements in depression, anxiety, demoralization and well-being and no serious adverse effects. The study is available at https://journals.sagepub.com/doi/10.1177/02692163261416269. Filament continues to supply PEX010 to the open label extension of that study.
PEX010, Filament Health's botanical psilocybin drug candidate, underscores Filament's position as a leading supplier of pharmaceutical grade natural psilocybin, supporting more than 80 academic and philanthropic research studies worldwide. PEX010 is available in a standardized dosing range of 1, 5 and 25 mg from a single drug candidate, with a 0.5 mg dose to follow, produced using Filament's proprietary and patented extraction, purification and stabilization methods, giving investigators consistent composition across every dose, every study and every research site. On April 30, 2026, the Company completed its previously announced acquisition of Filament Health Corp., including its lead drug candidate, PEX010, and its portfolio of 77 issued patents across 13 patent families.
About Rhelion Life Sciences:
Rhelion Life Sciences is a science and research led company advancing the natural psychedelic drug discovery and development sector. Through its wholly owned subsidiary Filament Health Corp., the Company is developing naturally derived psilocybin drug candidates, including its patented PEX010, and supporting clinical research and compassionate use programs with leading institutions around the world.
For additional information:
Todd Shapiro
Chief Executive Officer & Director
Tel: 647-204-7129
Email: todd@rhelion.com
Website: www.Rhelion.com
Cautionary Statement Regarding Forward-Looking Statements
This press release contains certain "forward-looking information" within the meaning of applicable Canadian securities legislation. Such forward-looking information and forward-looking statements are not representative of historical facts or information or current conditions but instead represent only the Company's beliefs regarding future events, plans or objectives, many of which, by their nature, are inherently uncertain and outside of the Company's control. Often, but not always, forward-looking statements and information can be identified by the use of words such as "plans", "expects" or "does not expect", "is expected", "estimates", "intends", "anticipates" or "does not anticipate", or "believes", or variations of such words and phrases or state that certain actions, events or results "may", "could", "would", "might" or "will" be taken, occur or be achieved. Examples of such information include statements with respect to: the supply of PEX010 to the PSYCHED-PAL Phase 3 trial and the open label extension of the Phase I/II study; the conduct, enrolment and progress of the Phase 3 trial; the therapeutic potential of microdose psilocybin and PEX010, including for psychological and existential distress in palliative care; demand for standardized natural psilocybin; the anticipated future availability of a 0.5 mg dose alongside the existing 1, 5 and 25 mg doses; the completed acquisition of Filament Health and the expected integration of Filament's clinical infrastructure and intellectual property; and the future development, commercialization and regulatory approval of PEX010.
Forward-looking information in this news release is based on certain assumptions and expected future events, namely: the continued ability of Filament and Psilo Scientific Ltd. to manufacture and supply PEX010; the performance by BHRI and Filament of their respective obligations under their agreements; the continued progression, enrolment and funding of the Phase 3 trial; that the results of the Phase 3 trial will be consistent with the results of the Phase I/II study; the ability to obtain and maintain any required regulatory permits and approvals, including clinical trial, ethics, import and export authorizations; the successful integration of Filament Health following the completed acquisition; and general business, market and economic conditions. Risks, uncertainties and other factors involved with forward-looking information could cause actual events, results, performance, prospects and opportunities to differ materially from those expressed or implied by such forward-looking information, namely: the risk that either party does not perform its obligations under their agreements; the risk that the Phase 3 trial does not proceed, enrol or progress as anticipated; the risk that the Phase 3 trial does not confirm the results of the Phase I/II study or does not produce positive or clinically meaningful results; the risk that funding for the trial is reduced, delayed or withdrawn; delays in regulatory permitting, including clinical trial, ethics, import and export authorizations; regulatory or enforcement developments affecting the legal framework for psilocybin supply and research; the risk that the 0.5 mg dose does not become available as anticipated; the risk that integration of Filament Health is not completed as anticipated; and adverse changes in the regulatory or political landscape affecting psychedelic research and access, together with the other risk factors described in the Company's continuous disclosure documents available under the Company's profile on SEDAR+ at www.sedarplus.ca. Readers are cautioned that the foregoing list is not exhaustive.
Although the Company believes that the assumptions and factors used in preparing, and the expectations contained in, the forward-looking information and statements are reasonable, undue reliance should not be placed on such information and statements, and no assurance or guarantee can be given that such forward-looking information and statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such information and statements. The forward-looking information and forward-looking statements contained in this press release are made as of the date of this press release, and the Company does not undertake to update any forward-looking information and/or forward-looking statements that are contained or referenced herein, except in accordance with applicable securities laws.
Source: Rhelion Life Sciences Corp.
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/315164
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
What patient population will the PSYCHED-PAL Phase 3 trial study?
The Phase 3 PSYCHED-PAL trial will enrol 120 participants with advanced illness who are experiencing psychological distress, such as depression, anxiety and loss of meaning. Participants will be recruited from inpatient, outpatient and community palliative care settings across seven sites in Canada.
How will PEX010 be administered in the palliative-care setting?
Participants will take small daily microdoses of psilocybin designed not to cause hallucinations and that do not require accompanying psychotherapy. This dosing approach is intended to be practical and acceptable for patients near the end of life.
What were the key findings of the earlier PSYCHED-PAL Phase I/II study using PEX010?
The earlier Phase I/II PSYCHED-PAL study, which also used PEX010, found microdose psilocybin to be safe, feasible and potentially effective for psychological distress in a palliative setting. Participants reported improvements in depression, anxiety, demoralization and well-being, and there were no serious adverse effects reported.
What standardized dosing options of PEX010 are currently available to investigators?
PEX010 is available in a standardized dosing range of 1, 5 and 25 mg from a single drug candidate, with a 0.5 mg dose planned to follow. The product is manufactured using Filament’s proprietary extraction, purification and stabilization methods to provide consistent composition across doses, studies and sites.
What is Filament Health’s broader role in psilocybin research beyond this trial?
Filament Health supplies PEX010, its botanical psilocybin drug candidate, to more than 80 academic and philanthropic research studies worldwide and continues to provide PEX010 to the open-label extension of the earlier PSYCHED-PAL study.