Psyence BioMed Doses First Patient in 25mg Psilocybin Phase IIb Trial
Psyence BioMed has dosed the first patient in its Phase IIb NPX-5 trial, administering 25 mg of nature-derived psilocybin to cancer patients with adjustment disorder across five Australian sites. The randomized, double-blind, three-arm study will assess safety, efficacy, and treatment durability in a palliative care setting.
1. Patient Dosing Initiated
Psyence BioMed has administered the first 25 mg dose of NPX-5 to a patient with adjustment disorder related to cancer in a palliative care setting. This milestone marks the start of systematic human data generation across five clinical sites in Australia.
2. Trial Design and Objectives
The Phase IIb study is randomized, double-blind and includes three dose levels to evaluate the safety, clinical response and symptom reduction, as well as the durability of treatment effects. Data collected will inform potential regulatory pathways and future development strategy.
3. Platform Integration Strategy
NPX-5 is produced under GMP-compliant conditions within Psyence BioMed’s vertically integrated platform, which combines manufacturing, clinical development and global supply capabilities. This alignment aims to support ongoing trial activities and prepare for future commercialization.