Rhelion Life Sciences' Wholly Owned Subsidiary Filament Health Signs Licence Agreement with the University of California, San Francisco for a Phase 2 Trial of Psilocybin in Methamphetamine Use Disorder Among People with HIV
Filament will provide trial capsules and regulatory documentation, including authorization to reference its drug master files.
Sentiment and the balance of points
Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.
Rhea-AI Summary
Rhelion Life Sciences (TRUFF) subsidiary Filament Health signed a licence and supply agreement with UCSF for a Phase 2 psilocybin trial. Filament will supply PEX010, its botanical psilocybin drug candidate, for PRISM, studying methamphetamine use disorder among people living with HIV.
The trial will enroll 30 participants with moderate to severe methamphetamine use disorder, randomly assigned equally to a single monitored 25 mg or 5 mg dose. The 5 mg dose is the active comparator; participants, care providers, investigators and outcome assessors will be masked to dose. Primary outcomes are feasibility, acceptability, safety and tolerability. The trial is expected to begin in November 2026 at Zuckerberg San Francisco General Hospital. UCSF's Dr. Nicky J. Mehtani is the sponsor; Filament is not responsible for trial conduct. The National Institute on Drug Abuse supports the work.
Positive
- Minor pointUCSF licence and supply agreement adds a Phase 2 trial using Filament's PEX010.
- Minor point. Forward-looking: it has not happened yet and may not happen.Trial initiation is expected in November 2026 at Zuckerberg San Francisco General Hospital.
Negative
- None.
AI-generated analysis. How Rhea-AI works. Not financial advice.
- Filament will supply PEX010 to a University of California, San Francisco trial testing whether a single dose of psilocybin can be used to help people living with HIV reduce methamphetamine use, a condition with no approved medication.
Toronto, Ontario--(Newsfile Corp. - October 8, 2026) - Rhelion Life Sciences Corp. (CSE: RHEL) (FSE: 4YX0) (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 Filament has entered into a licence and supply agreement with the University of California, San Francisco ("UCSF") for the supply of PEX010 to the Phase 2 trial titled "PRISM: Psilocybin Recovery Intervention for Stopping Methamphetamine use" (NCT07756736).
The trial will enroll 30 participants who are living with HIV and have moderate to severe methamphetamine use disorder. Participants will be randomly assigned in equal numbers to a single monitored dose of PEX010 at either 25 mg or 5 mg, with the 5 mg low dose serving as the active comparator. The trial is quadruple blinded, meaning participants, care providers, investigators and outcomes assessors are all masked to dose. Each dosing session is supported by three preparation and three integration motivational support therapy visits, and eligible participants may receive one additional open label 25 mg session after the four week assessment. The trial is expected to begin in November 2026 at UCSF's site at Zuckerberg San Francisco General Hospital, and its primary outcomes are feasibility, acceptability, safety and tolerability.
The trial is conducted under a sponsor-investigator Investigational New Drug application, IND 180587, held by Dr. Nicky J. Mehtani, MD MPH of UCSF, who is the sponsor of the trial, with Dr. Jennifer Mitchell, PhD as co-principal investigator. The work is supported by the National Institute on Drug Abuse. Filament is not the sponsor of the trial and is not responsible for its conduct.
Under the agreement, Filament will supply PEX010 in 25 mg and 5 mg capsules for use in the United States, together with the regulatory support documentation the trial requires, including certificates of analysis and batch certificates for each lot supplied, the current Investigator's Brochure, and a letter of authorization allowing the sponsor-investigator to reference Filament's drug master files in its submissions to the U.S. Food and Drug Administration.
There is no medication approved by the U.S. Food and Drug Administration for methamphetamine use disorder. Methamphetamine use is also associated with poorer outcomes among people living with HIV, including reduced adherence to antiretroviral treatment, which is why this trial studies the two together.
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 78 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.
About UCSF:
The University of California, San Francisco (UCSF) is exclusively focused on the health sciences and is dedicated to promoting health worldwide through advanced biomedical research, graduate-level education in the life sciences and health professions, and excellence in patient care. UCSF includes UCSF Health — a leading academic health system with top-ranked hospitals, specialty care, and affiliations throughout the Bay Area — and is recognized globally for its cutting-edge research, clinical innovation, and training of health professionals. Visit ucsf.edu or see our Fact Sheet for more information.
The information stated in this release was prepared by Rhelion Life Sciences Corp. and reflects solely the opinion of Rhelion Life Sciences Corp. Nothing in this statement shall be construed to imply any support or endorsement of Rhelion Life Sciences Corp., Filament Health Corp., or any of their products, by the Regents of the University of California, its officers, agents and employees.
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 PRISM trial; the provision of regulatory support documentation and a letter of authorization referencing Filament's drug master files; the initiation, conduct, enrolment and progress of the PRISM trial, including its expected start in November 2026; the therapeutic potential of psilocybin and PEX010, including for methamphetamine use disorder among people living with HIV; the obtaining and maintenance of import permits, controlled substance registrations and export authorizations required to ship PEX010 into the United States; 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 UCSF, the sponsor-investigator and Filament of their respective obligations under the licence agreement; the continued progression, enrolment and funding of the PRISM trial, including continued support from the National Institute on Drug Abuse; the ability to obtain and maintain any required regulatory permits and approvals, including clinical trial, ethics, import and export authorizations and controlled substance registrations; 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 the licence agreement; the risk that the supplied product does not meet specification on release testing; the risk that the trial does not begin in November 2026, or does not proceed, enrol or progress as anticipated, 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 and controlled substance registrations; 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/318082
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
What will the UCSF Phase 2 trial using Rhelion subsidiary Filament's PEX010 study?
The trial will study a single monitored psilocybin dose in 30 participants living with HIV and moderate to severe methamphetamine use disorder. Participants will be randomly assigned equally to 25 mg or an active comparator of 5 mg. Primary outcomes are feasibility, acceptability, safety and tolerability.
When is the UCSF trial using Filament Health's PEX010 expected to begin?
The trial is expected to begin in November 2026 at UCSF's site at Zuckerberg San Francisco General Hospital.
What therapy and additional dosing are planned in the UCSF PEX010 trial?
Each dosing session includes three preparation and three integration motivational support therapy visits. Eligible participants may receive one additional open-label 25 mg session after the four-week assessment; open-label means the dose is not masked.
What regulatory support will Filament provide for the UCSF PEX010 trial?
Filament will provide regulatory support documentation alongside 25 mg and 5 mg capsules for use in the United States. This includes certificates of analysis and batch certificates for each supplied lot, the current Investigator's Brochure, and authorization for the sponsor-investigator to reference Filament's drug master files in FDA submissions.