Psyence BioMed gets approval for psilocybin product in phase IIb trial

Psyence Biomedical Ltd. (NASDAQ: PBM) received approval from the Bellberry Human Research Ethics Committee to use PsyLabs' psilocybin product in its ongoing Phase IIb clinical trial for Adjustment Disorder in cancer patients.

The approval covers the use of PsyLabs' psilocybin formulation (NPX5) at all participating study sites, including Empax Centre, Mind Medicine Australia Clinic, and Paratus Clinical Research in Melbourne. The company plans to activate additional clinical sites to accelerate patient recruitment.

The Phase IIb study will enroll approximately 87 participants to evaluate two therapeutic doses of psilocybin against a low-dose comparator, combined with structured psychotherapy. The company expects to deliver top-line results in 2026.

Psyence BioMed reported cash reserves of approximately $9.5 million with no debt. The company develops nature-derived psilocybin and ibogaine therapies for mental health conditions.

"We are extremely pleased that PsyLabs' nature-derived psilocybin product has now been formally approved for use in our Phase IIb study," said Jody Aufrichtig, CEO of Psyence BioMed.

PsyLabs operates from an ISO 22000-certified facility and has exported psilocybin products to Canada, the UK, Portugal, and Slovenia. The company holds federal licenses to cultivate, extract, and export psilocybin mushrooms and other psychedelic compounds including psilocin, mescaline, ibogaine, and dimethyltryptamine.

The approval followed review of updated clinical documentation, including the amended protocol, investigator brochure, and participant information materials reflecting the transition to PsyLabs' psilocybin formulation.

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