SEED Innovations Ltd (AIM:SEED, OTC:FFRIF) hailed the regulatory approval for investee company Little Green Pharma to start a clinical trial into psilocybin.
Little Green's own subsidiary, Reset Mind Sciences, will carry out a 12-month trial in Australia to test the efficacy and safety of psilocybin-assisted psychotherapy in treating major depressive disorder, according to a statement.
Psilocybin is the naturally occurring psychedelic found in what are called 'magic mushrooms' and hundreds of other species of fungi.
Reset Minds received approval from the Human Research Ethics Committee of Australia.
As part of the study, family members of those suffering from major depressive disorder will feature in the preparatory and integration therapy sessions that precede and follow the administration of psilocybin, it said.
Recruitment for the trial is expected to start in the second quarter of 2023, which will feature roughly 60 participants and take place at the Harry Perkins Institute of Medical Research in Perth, alongside Fiona Stanley Hospital.
"The trial will be one of the first psilocybin-assisted therapy trials in Australia and we trust it will contribute meaningfully to the clinical evidence supporting the use of psilocybin and other psychedelics for the treatment of chronic mental illness in Australia,” said Reset chief executive Shaun Duffy.
Earlier this month, SEED, Little Green and Reset welcomed the change in the classification of psilocybin and MDMA in Australia.
As part of the decision by the Therapeutic Goods Administration (TGA), an Australian government agency, psilocybin and MDMA may be prescribed by authorised psychiatrists.