As Australia becomes the first country in the world to officially recognise psychedelics as medicines, Creso Pharma’s subsidiary has positive early results from a  Phase-2 trial.

Creso Pharma (ASX:CPH) has announced its wholly owned subsidiary, Halucenex Life Sciences has reported positive early results from its Phase-2 clinical trial to test the efficacy of psilocybin on treatment-resistant post traumatic stress disorder (PTSD).

The early results also led the Canadian-based Halucenex to seek a clinical trial amendment (CTA) to streamline the clinical trial process.

The amendment was approved via Health Canada on April 26 and includes a larger window for pre-screening and approval for Halucenex’s chief science officer to prepare doses without the need for a compounding pharmacist.

Changes also include the ability to spread each patient’s seventh visit over 1-3 days. CPH said the key amendments will help streamline the trial, de-risking attrition rates and mitigating scheduling stressors for participants.

Trial background and promising early results

The trial is a single-arm, open-lab trial to test the efficacy of psilocybin on PTSD symptoms.

The trial uses Halucenex’s 100%-owned and formulated synthetic psilocybin aqueous solution Lucenex, in both 10mg and 25mg formats which is being delivered to 20 respective patients on separate occasions in a micro dose and macro dose format.

Of the 20 trial participants, only two patients to-date have received an initial dosing, which took place in December 2022.

Review of initial data has found that two psilocybin doses (one micro dose and one macro dose) spread one week apart leads to a marked decrease of PTSD symptoms in patients with severe treatment-resistant PTSD.

Additional results from two-patient cohort immediately post macro dose included:

  • Notable improvements in total sleep time
  • Reduced cravings and need for THC during day time and for sleep
  • Reported reduced cravings for junk food
  • Significant improvements in blood pressure readings at follow-up visits (from hypertensive to normal)
  • Social improvement with interpersonal relationships
  • Symptoms of suicidal ideation were unchanged since neither patient endorsed suicidal ideation

The patients who completed three months of assessments to-date reported a 95% reduction in symptoms at month one and a 75% reduction in symptoms by month three, with one patient experiencing a total remission of PTSD by month three.

Percentage decline in PTSD symptoms from Lucenex-branded psilocybin treatment. Pic: Supplied (CPH).

Pathway into Aussie market following landmark TGA decision 

Australia has become the first country in the world to officially recognise psychedelics as medicines following a landmark decision by the  Therapeutic Goods Administration (TGA).

The TGA approved psychedelic substances used in magic mushrooms and MDMA, making Australia the first country in the world to recognise psychedelics as medicine.

From July 1 this year, medicines containing the psychedelic substances psilocybin and MDMA (3,4-methylenedioxy-methamphetamine) can be prescribed by authorised psychiatrists in Australia for treating certain mental health conditions. 

CPH is progressing groundwork for a commercial pathway into the Aussie market following the TGA decision.

Among mental health conditions the TGA listed for treatment using the psychedelic substances is PTSD.

CPH CEO and managing director William Lay said the initial results from the Phase-2 clinical trial were pleasing and indicate the early promise of the Lucenex branded synthetic psilocybin product as a viable treatment option for patients suffering from treatment-resistant PTSD symptoms.

“As the trial continues, we look forward to providing more details on patient results and our ongoing dialogue with regulators,” he said.

“Amid broader regulatory tailwinds for the psilocybin products, we are confident the current Phase-2 trial will continue to establish a strong platform for the future commercial application of our products.”

This article was developed in collaboration with Creso Pharma, a Stockhead advertiser at the time of publishing.

This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.