Creso Pharma Limited (ASX:CPH, FRA:1X8) ('Creso Pharma') is pleased to announce its wholly-owned psychedelics subsidiary, Halucenex Life Sciences Inc. ('Halucenex'), is exploring opportunities to register its synthetic psilocybin formulation for the Australian market following recent regulatory changes.

The Therapeutic Goods Administration (TGA), the medicine and therapeutic regulatory agency of the Australian Government, recently announced that the medical use of MDMA and psilocybin will be reclassified from Schedule 9 (prohibited substances) to Schedule 8 (controlled medicines). This ruling allows authorized psychiatrists to prescribe medicines containing MDMA and psilocybin for the treatment of certain mental health conditions as of July 1, 2023.

Based in Windsor, Nova Scotia, Halucenex is currently undertaking a Phase II clinical trial which will test the efficacy of psilocybin on treatment-resistant PTSD. The company has recruited 20 patients from the single-arm, open-lab trial that all suffer from the condition, in addition to other mental illnesses such as, but not limited to, anxiety, suicidal thoughts, ADHD, depression and anger.

Creso Pharma is confident that the data generated from the Halucenex trial will provide a strong foundation for the registration of the company's Lucenex-branded synthetic psilocybin product as a potential treatment option in Canada and Australia, pending further regulatory requirements. Halucenex is already a Licensed Psilocybin Supplier under Health Canada's Special Access Program.

"This is a watershed moment for psychedelic therapy in Australia," said Creso Pharma CEO and Managing Director William Lay. "The TGA's decision provides considerable validation of Halucenex's work to date, and it highlights the significant potential Creso Pharma has as an early stage pioneer of medical psilocybin."

"Halucenex's clinical trial is advancing pleasingly," continued Lay. "We are confident that data generated from the initiative will provide a much greater insight into how Lucenex can be used as a potential treatment route for debilitating health conditions."

Creso Pharma and Halucenex will continue to work alongside Australian-based research organizations and potential partners to further progress these initiatives.