Rhelion unit to supply psilocybin for UCSF HIV-meth study

Rhelion Life Sciences Corp. (CSE: RHEL, FSE: 4YX0, OTCQB: TRUFF) announced that its wholly owned subsidiary, Filament Health Corp., has signed a license and supply agreement with the University of California, San Francisco to provide its botanical psilocybin drug candidate, PEX010, for a Phase 2 clinical trial.

The trial, titled "PRISM: Psilocybin Recovery Intervention for Stopping Methamphetamine use" (NCT07756736), will enroll 30 participants living with HIV who have moderate to severe methamphetamine use disorder. No medication is currently approved by the U.S. Food and Drug Administration for methamphetamine use disorder.

Participants will be randomly assigned to receive a single monitored dose of PEX010 at either 25 mg or 5 mg, with the lower dose serving as an active comparator. The trial is quadruple blinded, covering participants, care providers, investigators, and outcomes assessors. Each dosing session is supported by three preparation and three integration motivational support therapy visits. Eligible participants may receive one additional open-label 25 mg session after a four-week assessment.

The trial is expected to begin in November 2026 at UCSF's Zuckerberg San Francisco General Hospital. Primary outcomes are feasibility, acceptability, safety, and tolerability. The study is conducted under an Investigational New Drug application held by Dr. Nicky J. Mehtani of UCSF, with Dr. Jennifer Mitchell as co-principal investigator, and is supported by the National Institute on Drug Abuse. Filament is not the trial sponsor.

Under the agreement, Filament will supply PEX010 in 25 mg and 5 mg capsules for use in the United States, along with regulatory support documentation including certificates of analysis, batch certificates, the current Investigator's Brochure, and a letter of authorization to reference Filament's drug master files in submissions to the FDA.

Rhelion completed its acquisition of Filament Health Corp. on April 30, 2026. The company states PEX010 is currently supporting more than 80 academic and philanthropic research studies worldwide.

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