Psyence Biomed hires Southern Star for Phase II psilocybin study

Psyence BioMed has hired Southern Star Research to run a clinical trial of the magic mushroom-derivative psilocybin in patients with adjustment disorder.

The study — a Phase IIb trial — will examine the drug as a treatment for the psychological condition in people diagnosed with cancer.

According to a recently published letter of intent, Sydney, Australia-based contractor Southern Star will manage the study at sites across the country.

A Psyence spokesperson told Clinical Insider, “We selected Southern Star because of their experience managing complex clinical trials and their deep connections across national oncology and mental health networks.”

Spokesperson added, “Their strong relationships with clinical sites and investigators will allow us to accelerate patient recruitment and expand our trial’s reach.

“Southern Star’s scale and operational capabilities are well-suited to support the next phase of our clinical development, helping us to maintain momentum and meet our milestones.”

Psyence anticipates that patient recruitment will be completed in the first half of 2026, with primary endpoint analysis expected in the second half of the year.

CRO change

Previously, Psyence worked with Melbourne-based iNGENū CRO and site management organization Australian Clinical Trial Network.

The decision to have Southern Star take over reflects Psyence’s desire to expand the scope of the study and accelerate timelines, according to the spokesperson.

“Southern Star brings the network reach and operational scale required to support this evolution.

“We’re grateful to iNGENū for their important early contributions — particularly in protocol development, ethics approval, and site activation — and we are working closely with both teams to ensure a smooth and seamless transition,” the spokesperson added.

Supplies for the Phase IIb study will be provided by Filament Health, a Canadian firm Psyence signed an agreement with in 2022.

Psilocybin

In related news, Psyence licensed psilocybin from psychedelics pharmaceutical manufacturer Optimi Health Corp in 2024.

The agreement granted the firm exclusive rights to use Optimi’s psilocybin products for research and clinical trials aimed at treating anxiety, depression, and related conditions within palliative care.

According to the spokesperson, “Our agreement with Optimi covers future trials.”

DepositPhotos/sdecoret