Mr. Todd Shapiro reports
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
Through Rhelion Life Sciences Corp.'s wholly owned subsidiary, Filament Health Corp., the company develops, manufactures and supplies PEX010, its patented, standardized, GMP (good manufacturing practice) 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 milligrams or five mg, with the five 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 five 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 United States 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 one, five 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 Corp.
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.
The information stated in this release was prepared by Rhelion Life Sciences and reflects solely the opinion of Rhelion Life Sciences. Nothing in this statement shall be construed to imply any support or endorsement of Rhelion Life Sciences, Filament Health or any of their products, by the regents of the University of California, its officers, agents and employees.
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