Psyence Biomedical (Psyence BioMed) has dosed multiple participants in its ongoing Phase IIb clinical study assessing nature-derived psilocybin alongside psychotherapy as a potential therapy for adjustment disorder in palliative care.
The Phase IIb trial is said to be the only active Australian clinical programme employing a natural psilocybin formulation for this indication.
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Its design aims to meet regulatory standards for pivotal clinical evidence, incorporating multisite operations, a larger sample size, and rigorous randomisation. This approach increases data reliability, improves statistical power, and broad applicability of the results.
Participants have now been administered doses at two Australian locations, the Mind Medicine Australia Clinic in Melbourne and the Empax Centre in Perth.
The activation of Paratus Clinical Research in Melbourne expands this network to three locations, accelerating data collection and advancing recruitment, with topline results expected by 2026’s end.
Psyence BioMed medical director Dr Clive Ward-Able said: “The randomisation and dosing of these patients across multiple independent trial sites marks an exciting and validating milestone for Psyence BioMed.
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By GlobalData“With multiple sites now operational and patients progressing through screening, we are seeing strong interest and momentum. This level of engagement reinforces the importance of our work in developing psilocybin-based therapies for palliative care.”
A total of 87 participants will be enrolled in this placebo-controlled, double-blind trial. Each of them will receive one of two psilocybin doses (10mg or 25mg) or a low-dose comparator (1mg), combined with structured psychotherapy.
The trial will evaluate durability, efficacy, and safety, aiming to establish psilocybin as a first-in-class option for adjustment disorder in palliative settings.
Psyence BioMed CEO Jody Aufrichtig said: “This pivotal moment reflects the extraordinary effort and precision required to achieve multiple patient dosing across independent clinical sites.
“It demonstrates not only our team’s operational excellence but also the maturity of our clinical infrastructure.”
