Psyence BioMed has received formal approval from the Bellberry Human Research Ethics Committee (HREC), Australia, to use psychedelic active pharmaceutical ingredient (API) developer, PsyLabs’ psilocybin product (NPX5) in its ongoing Phase IIb study.
The trial is focused on assessing psilocybin-assisted psychotherapy for adjustment disorder in cancer patients.
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PsyLabs holds the federal licence for cultivating, extracting, and exporting psilocybin mushrooms and other psychedelic compounds for legal medical and research purposes.
The approval from Bellberry HREC follows a review of updated clinical documentations, including the investigator brochure, amended protocol, and participant information materials.
The authorisation covers all participating trial sites, which include Mind Medicine Australia Clinic, Empax Centre, and Paratus Clinical Research in Australia.
Psyence BioMed said that it started planning the additional site activation to expedite patient recruitment further and progress the Phase IIb programme.
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By GlobalDataIt holds an investment in PsyLabs, significant clinical assets, and a cash reserve of around $9.5m.
The Phase IIb trial is set to enrol around 87 subjects, assessing two psilocybin therapeutic doses against a low-dose comparator, all in conjunction with structured psychotherapy.
With several sites activated and recruitment ongoing, the trial is projected to deliver top-line outcomes next year.
Psyence BioMed CEO Jody Aufrichtig said: “We are extremely pleased that PsyLabs’ nature-derived psilocybin product has now been formally approved for use in our Phase IIb study. This is a pivotal advancement in our clinical programme and a defining step in our long-term strategy.
“By incorporating what we believe is the best-in-class good manufacturing practice (GMP) compliant psilocybin product on the market – developed entirely within our vertically integrated structure – we are reinforcing supply-chain control, manufacturing excellence, and scalable production capacity that will drive future commercial success.”
PsyLabs CEO Tony Budden said: “Having our psilocybin formulation cleared for clinical use is a transformative moment for PsyLabs. It reflects years of scientific, regulatory, and manufacturing preparation to ensure our product meets the highest standards for purity, repeatability, and patient safety.
“We are proud to support Psyence BioMed’s mission to bring safe, nature-derived psychedelic therapies into regulated medicine.”
