Creso Pharma welcomes Halucenex appointment of True North as lead investigator for ground-breaking clinical trial into psychedelic treatment for PTSD

Creso Pharma Ltd's (ASX:CPH) (FRA:1X8) target acquisition company Halucenex Life Sciences has appointed True North Clinical Research as principal investigator for its proposed Phase II Clinical Trial to test the efficacy of psilocybin for treatment-resistant Post Traumatic Stress Disorder (PTSD) in veterans and first responders. Creso made history this week as the first ASX-listed psychedelics stock by the acquisition of Halucenex, a life sciences development company focused on researching, developing and licensing novel psychedelic molecules for the global pharmaceutical and nutraceutical markets. The move capitalises on growing interest in psychedelic medicines, a market opportunity which Canaccord Genuity has estimated at US$100 billion, including LSD and psilocybin mushrooms as treatments for a range of mental illnesses such as post-traumatic stress disorder, anxiety and depression. True North to oversee clinical trial Halucenex has engaged True North because its locations are geographically favourable for participants, its team of more than 30 clinicians have considerable experience in providing patient care and the group’s CEO Dr Mark Johnson has considerable experience with the Armed Forces, developed over a 20-year career as a psychiatrist with various military organisations.  Creso non-executive chairman Adam Blumenthal said: “The appointment of True North is a pleasing development for Halucenex and we are excited that the company is already making progress with its proposed clinical trial schedule.  “The appointment of True North will provide the necessary infrastructure needed to undertake a necessary and potentially ground-breaking research initiative.” As lead investigators, True North will provide clinical oversight into the trial, assist with facilitation of compliancy with the Nova Scotia Ethics Committee, undertake patient recruitment initiatives, conduct the trial, monitoring, data capture and compilation of results and ensure follow up measures are taken to ensure participant safety.  “Ground-breaking PTSD research”  Halucenex founder and CEO Bill Fleming said the company was proud to be working with True North to progress the development of its future breakthrough therapy for veterans and first responders and help them fight against mental illness.  He said: “This trial will allow us to bring out clinical trial expertise and psychological expertise together, to maximise the benefit for current and future patients.  “Veterans and first responders give so much to society on a daily basis and we owe it to them to find the most effective treatments possible.  “This trial is a major step in the right direction.”  True North founder Dr Mark Johnston agreed: “Despite more than a million veterans around the world being diagnosed with PTSD, effective pharmacological treatments are sorely lacking, which is why True North is excited to work with Halucenex to undertake this ground-breaking research.”  Psilocybin phase II clinical trial The Phase II, single-arm, open-label trial will determine the efficacy and safety of psilocybin in subjects with treatment-resistant PTSD.  Around 18 to 20 subjects with treatment- resistant PTSD will be enrolled into the trial, and will be treated with two oral doses of psilocybin separated by seven days, with a 10mg micro dose of psilocybin to be administered in the clinic on Day 7 and a follow up macro dose of 25 mg to be administered in the clinic on Day 14.  At 6 to 7 hours post-dosing, subjects will be assessed using patient ratings of subjective intensity of psilocybin’s effects and will also complete the patient verbal rating of the intensity of the subjective effects.  One day after each treatment (on Day 8 and Day 15), subjects will return to the clinic for efficacy and safety assessments, with follow-up visits to be conducted at the clinic on Day 22 and via telephone visits on Day 36, and Day 90 and Day 180 (optional) for efficacy and safety assessments.  Patient identification criteria has already begun, with the trial expected to commence in June 2021, subject to a Clinical Trial Authorisation (CTA) Permit being awarded by Health Canada.  Halucenex intends to lodge the required documentation to obtain the CTA Permit by the end of April 2021 and expects initial results within the first months of trial commencement.  Halucenex acquisition progressing  The seamless integration of Halucenex into the Creso Phama Group is underway, and Creso is confident that the PTSD market – which is expected to grow to US$10.5 billion by 2025 - represents a major opportunity for the companies. Blumenthal said: “Board and management continue to undertake due diligence on the acquisition and the exciting opportunities this will unlock for Creso Pharma, as it transitions to a best in class provider of cannabis, cannabinoids and psychedelic alternative medicines to meet the large unmet need for treatments to improve mental health and wellbeing.” As part of the acquisition, the company has advised that director Dr Miri Halperin Wernli will resign today and will be replaced by Halucenex founder and CEO Bill Fleming who is proposed to join the Creso board as a non-executive director upon completion of the transaction.