In Australia, about 43% of people aged between 16 and 85 had experienced a mental disorder at some point as of 2023. Between 2021 and 2022, over 44 million mental health-related meds, largely anti-depressants, were dispensed. While traditional treatments are only about 20 to 30% effective in treating anxiety and depression, recreational cannabis company Melodiol (ASX: ME1) trials reveal that its drug displays greater effectiveness—not only for anxiety and depression but also PTSD. 

The Company revealed results from the Phase II clinical trial undertaken by its wholly-owned psychedelics subsidiary Halucenex Life Sciences, testing the efficacy of psilocybin, or magic mushrooms, on treatment-resistant Post Traumatic Stress Disorder (PTSD).  Five patients have undergone testing, with 80% of participants experiencing total respite from PTSD symptoms following two doses of Halucenex’s 100%-owned synthetic psilocybin aqueous solution Lucenex.

CEO and Managing Director, William Lay, said, “Results from the first five patients that have undergone psilocybin dosage using our unique Lucenex solution, are nothing short of exceptional. A remission rate of 80% by day 44 of treatment provides considerable validation of Halucenex’s approach and potential as a viable treatment option for patients suffering from treatment-resistant PTSD symptoms.”

In February 2023, the Therapeutics Goods Administration of Australia changed the classifications of MDMA and mushrooms from prohibited to controlled substances starting in July. As per the change, mushrooms can be prescribed for treatment-resistant depression. 

The trial, which commenced in December 2022, is a single-arm, open lab trial to test the efficacy of psilocybin on treatment resistant PTSD symptoms. The trial utilises Lucenex in both 10mg and 25mg formats, delivered to 20 patients on separate occasions in a microdose and macro dose format.

Additional results from the first five patients include a 50% reduction in anxiety scores on day 44 of treatment and a 57% reduction in depression scores. These results mark a major achievement, unlocking future commercial opportunities for the Company.

The trial also found that three of the five participants who scored in a moderate to severe range for depression had reduced to a normal range by day 44 of treatment. The Company will utilise its preliminary results in ongoing discussions with potential partners and collaborators.

Halucenex’s Clinical Research Director, Dr Lisa Batten, added, “Having worked with treatment-resistant mental health disorders my entire career, I’ve seen first-hand the devastating impact of these conditions and the frustrations from lack of effective treatment options. Our psilocybin research shows evidence of an intervention that rapidly treats the underlying pathology rather than offering temporary solutions to get people through their days. It’s an exciting prospect to see someone get their life back.”

In H1 2023, Melodiol’s revenues amounted to $6.9 million, a 62% increase on H1 2022’s $4.3 million. In the same period, Melodiol signed a letter of intent to divest two of its fully-owned subsidiaries, including Halucenex, to US-based Panacea for $7.8 million. The divestment aims to pump more cash into the Company.

Halucenex will continue to advance first dosages with another 15 trial candidates over the coming months. Reports thus far signal a potentially life-altering treatment path for people living with the repercussions of PTSD.