Creso Pharma Ltd (ASX:CPH, OTCQB:COPHF) has received “promising” early results from its wholly owned psychedelics subsidiary Halucenex Life Sciences Inc.'s Phase 2 clinical trial to test the efficacy of psilocybin in treating post-traumatic stress disorder (PTSD).
The initial data from the first two patients who received the psilocybin dose showed a marked decrease in PTSD symptoms, with one patient experiencing total remission after the first macro-dose.
Notably, the trial is being conducted using Halucenex's wholly owned and formulated synthetic psilocybin aqueous solution, Lucenex.
Looking ahead, the positive results have led the company to apply for a Clinical Trial Amendment (CTA) to streamline the clinical trial process.
Broader regulatory tailwinds for psilocybin
Creso CEO and managing director William Lay said: “We are pleased to report the initial results from our Phase 2 clinical trial, which clearly 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.
“Amid broader regulatory tailwinds for the psilocybin products, we are confident the current phase II trial will continue to establish a strong platform for the future commercial application of our products.”
CTA approval
The company also secured approval for a CTA to further streamline the trial.
The amendment includes a larger window for pre-screening, approval for Halucenex’s chief science officer to prepare doses without the need for a compounding pharmacist, and the ability to spread each patient’s seventh visit over 1-3 days.
These amendments will help streamline the trial, reduce attrition rates, and mitigate scheduling stressors for participants.
Promising early results
In addition to promising early results, the initial two-patient cohort immediately post macro-dose reported notable improvements in total sleep time, reduced cravings and need for THC during daytime and sleep, reduced cravings for junk food, and significant improvements in blood pressure readings at follow-up visits.
The social improvement in interpersonal relationships and no changes in suicidal ideation symptoms were also reported.
All 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. One patient experienced total remission of PTSD by month three.
Trial background
The clinical trial is a single-arm, open-lab trial testing the efficacy of psilocybin on PTSD symptoms using Halucenex's 100% owned and formulated synthetic psilocybin aqueous solution, Lucenex, in both 10mg and 25mg formats.
Twenty respective patients receive psilocybin on separate occasions in micro and macro doses.
The trial kicked off in October 2022, with the first dosing taking place in December 2022.
All psychiatric disorders were confirmed and diagnosed at the baseline assessment using the Structured Clinical Interview for DSM-5 (SCID-5).
Symptoms of PTSD were assessed at each visit using the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5). Participants were enrolled if they had a score of ≥40, indicating severe symptoms of PTSD.
Remission of PTSD was defined as a score of ≤ 20 on the CAPS-5.
Pathway to the Australian market
Creso Pharma continues to progress the groundwork for a commercial pathway into the Australian market.
The therapeutic goods administration (TGA) has indicated that from July 1, medicines containing psilocybin and MDMA for prescription by specifically authorised psychiatrists for the treatment of certain medical conditions would be permissible.
The CTA secured by the company will further streamline the clinical trial process, de-risk attrition rates, and mitigate scheduling stressors for participants.