Halucenex prepares for PTSD clinical trials

Creso Pharma Limited’s (ASX: CPH; FRA: 1X8) targeted acquisition company, Halucenex Life Sciences has appointed True North Clinical Research (True North) as the principal investigator for its proposed Phase II Clinical Trial.

This trial will test the efficacy of psilocybin for the treatment of resistant Post Traumatic Stress Disorder (PTSD) in veterans and first responders.

Halucenex, which is set to become part of the Creso Pharma Group as advised on 15 March, is a life sciences development company focused on researching, developing and licencing novel psychedelic molecules for the global pharmaceutical and nutraceutical markets.

True North is a leader in research and development, focused on implementing industry best practises and providing the highest quality of care during clinical trial initiatives.

The group has a team of highly qualified research staff and all work undertaken adheres to stringent regulatory guidelines.

True North also has strong ties to the Canadian armed forces and veterans, which will be imperative to the trial.

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, as well as facilitating follow up measures to ensure participant safety.

Highlighting the desperate need for assistance for PTSD sufferers, True North founder Doctor Mark Johnson said, “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.”

With the PTSD therapeutics market expected to grow to US$10.5 billion by 2025, it appears that Creso Pharma has targeted a fast-growing, high demand market.

True North has Armed Forces experience and access to patients

One of the reasons Halucenex chose to engage True North was because its locations are geographically favourable for participants.

Further, its team of over 30 clinicians have considerable experience in providing patient care and Johnson has considerable experience with the Armed Forces, developed over a 20-year career as a psychiatrist with various military organisations.

The trial is a Phase II, single-arm, open-label trial to determine the efficacy and safety of psilocybin in subjects with treatment-resistant PTSD as it aims to ultimately determine the feasibility of future trials of psilocybin in this indication.

Approximately 18 to 20 subjects (18 years or older) with treatment-resistant PTSD will be enrolled into the trial which will be conducted at one study site.

Halucenex expects to recruit between 18 to 20 patients who will be treated with two oral doses of psilocybin separated by 7 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.

Documentation for CTA Permit to be lodged in April

Following treatment on each day, subjects will be closely monitored in the clinic by the study monitors during the hallucinogenic period.

Safety assessments will be conducted including incidents of adverse events and vital signs.

At 6 to 7 hours post-dosing, subjects will be assessed using patient ratings of subjective intensity of psilocybin’s effects.

Subjects 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.

Follow-up visits will be conducted at the clinic on Day 22 (end of treatment), and via telephone visits on day 36, month 3 and month 6 (optional) for efficacy and safety assessments.

Patient identification criteria have already begun, with the trial expected to commence in June 2021, subject to a Clinical Trial Authorisation Permit (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 initial results are expected within the first months of trial commencement.

Commenting on these developments and their broader implications with regard to ongoing research initiatives, 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.

"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.’’

Head of Halucenex to take on non-executive director role on completion

Creso Pharma’s Board and management team continue to progress a number of initiatives to ensure the seamless integration of Halucenex into the Creso Phama Group.

As part of the acquisition, director Dr Miri Halperin Wernli will resign today and will be replaced by Halucenex founder and chief executive Bill Fleming who is proposed to join the Creso Board as a non-executive director upon completion of the transaction.

Creso Pharma’s North American operations will continue to be spearheaded by Jack Yu and its Swiss operations will be driven by existing commercial director, Jorge Wernli, who has been responsible for the development and commercialisation of the company’s line of CBD-based nutraceutical products.

Commenting on the executive changes, Blumenthal said, “I would like to take this opportunity to thank Miri for her commitment to Creso Pharma.

"During her time in office, she has been pivotal in Creso Pharma’s success and delivered an immense amount of value to the Board and management team, as well as leading a number of initiatives that have unlocked considerable value for our shareholders.

"On behalf of my fellow directors and shareholders, I wish her all the best for her future undertakings.’’