Psyence Biomedical Ltd. received full approval from the Australian Health Research Ethics Committee (HREC) to initiate its planned Phase IIb study in Melbourne, Australia. The study will be conducted through PBM?s subsidiary, Psyence Australia (Pty) Ltd. and will examine the use of nature-derived psilocybin as a treatment for Adjustment Disorder due to a recent cancer diagnosis in the palliative care context. Accordingly, an estimated 56.8 million people worldwide require palliative care annually, with a substantial number of these patients exhibiting a high burden of psychosocial distress after diagnosis.

The news release goes on to state that Adjustment Disorder is a serious condition affecting around 19% of patients with a life-limiting diagnosis. It severely impacts the quality of life for patients, their families and caregivers, and regularly ranks among the top seven psychiatric diagnoses in the world, according to the World Health Organization. Psyence Australia has partnered with a noted psychedelic Contract Research Organization (CRO), iNGENu Pty Ltd. (?iNGENu?), to design and execute the clinical trial.

iNGENu is an Australia-based, globally focused CRO with extensive experience working in psychedelic pharmaceutical drug research and development. The double-blind, placebo-controlled Phase IIb study will test three doses (25mg, 10mg and 1mg) of nature-derived psilocybin in 84 patients in conjunction with psychotherapy. The primary endpoint is change in HAM-A (Hamilton Anxiety Rating Scale), a widely used tool to measure anxiety severity, over time.