Rhelion Life Sciences' Wholly Owned Subsidiary Filament Health Expands Supply Agreement with the University of Chieti-Pescara for PEX010 in the TEMPO Clinical Trial of Psilocybin for Treatment-Resistant Depression in Italy
The expanded supply matches an increase in TEMPO participants, though no participant count or agreement value was disclosed.
Rhea-AI Summary
Rhelion Life Sciences (TRUFF) expanded Filament Health's supply and licence agreement with the University G. d'Annunzio of Chieti-Pescara for the TEMPO trial in Italy.
The amendment increases supply of PEX010 25 mg capsules after the trial's participant count rose during regulatory review. TEMPO, a trial of psilocybin for treatment-resistant depression, was authorized under the European Union Clinical Trials Regulation. The University sponsors and conducts the trial. Filament supplies PEX010 and provides regulatory support for the trial and the drug's release for European Union use.
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- Following authorization of the TEMPO trial under the European Union Clinical Trials Regulation, Filament has expanded its supply agreement with the University G. d'Annunzio of Chieti-Pescara to support an increase in the number of trial participants.
Toronto, Ontario--(Newsfile Corp. - September 25, 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 expanded its supply and licence agreement with the University G. d'Annunzio of Chieti-Pescara (the "University") for the supply of PEX010 to TEMPO, a clinical trial of psilocybin for treatment-resistant depression conducted at the Psychiatric Clinic of the University in Chieti, Italy.
TEMPO was authorized under the European Union Clinical Trials Regulation (EU CT number 2025-523346-27-00). During the regulatory review, the number of trial participants was increased, and the amended agreement expands the supply of PEX010 25 mg capsules to match. Filament also provides regulatory support for the trial and release of PEX010 for use in the European Union.
The trial is coordinated with the Istituto Superiore di Sanità (the Italian National Institute of Health) and has been reported in the Italian press as the first clinical trial of psilocybin in Italy. The University is the sponsor of the trial. Filament is not the sponsor of the trial and is not responsible for its conduct.
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.
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 expanded supply of PEX010 to the TEMPO trial under the amended agreement; the release, export, import and delivery of PEX010 for the trial; the conduct, enrolment and progress of the TEMPO trial; the therapeutic potential of psilocybin and PEX010, including in treatment-resistant depression; 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 the University and Filament of their respective obligations under the amended agreement; the continued progression and funding of the trial; 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 the amended agreement; the risk that the supplied product does not meet specification on release testing; the risk that the trial 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; 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/316036
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