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Psyence BioMed begins dosing patients in phase IIb psilocybin trial

April 23, 2026 7:01 AM

Psyence Biomedical Ltd. (NASDAQ: PBM) announced that the first patient has been dosed in its Phase IIb clinical trial evaluating NPX-5 for the treatment of Adjustment Disorder in cancer patients receiving palliative care.

NPX-5 contains 25mg of nature-derived psilocybin and is manufactured under Good Manufacturing Practice standards. The compound was developed through Psyence BioMed's investment in PsyLabs as part of its vertically integrated platform.

The randomized, double-blind, three-arm study is designed to evaluate the safety and efficacy of 25mg psilocybin in patients experiencing Adjustment Disorder related to a cancer diagnosis. The trial is being conducted across five clinical sites in Australia, including research centers in Perth and Melbourne.

"Initiating patient dosing is an important step forward for our clinical program and, more importantly, for the patients we aim to support," said Jody Aufrichtig, Chief Executive Officer of Psyence BioMed.

The trial aims to generate data on clinical response and symptom reduction, safety and tolerability of NPX-5, and treatment durability in cancer patients. The company stated this data will inform future development strategy and potential regulatory pathways.

Dr. Neil Maresky, Global Head Clinical Development, said the study focuses on "disciplined execution, consistent patient recruitment, and the generation of high-quality data to support the advancement of this program."

Psyence BioMed describes itself as a clinical-stage biopharmaceutical company developing nature-derived psychedelic therapeutics. The company's psilocybin program represents a core component of its strategy to build a vertically integrated platform combining manufacturing, clinical development, and supply capabilities.

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