Creso Pharma Ltd (ASX:CPH, OTCQB:COPHF) psychedelics subsidiary Halucenex Life Sciences Inc has lodged a Clinical Trial Authorisation (CTA) with Health Canada for a planned phase II clinical trial to test the efficacy of psilocybin on treatment-resistant Post Traumatic Stress Disorder (PTSD).
The proposed phase II clinical trial is designed to be a single-arm, open-lab trial that will ultimately determine the feasibility of future trials of psilocybin in this indication.
Notably, the clinical trial is expected to add to the growing body of evidence for the use of psilocybin assisted psychotherapy which may derisk uptake and rollout.
Looking ahead, the CTA is subject to a 30-day review by Health Canada and an approval will allow Halucenex to commence its clinical trial during the June quarter of 2022.
“Significant competitive advantage”
Halucenex president, CEO and founder Bill Fleming said: “Lodging our CTA with Health Canada is the culmination of considerable hard work from the company.
“It includes a significant amount of data that has been generated from initiatives over the last 12 months and we are confident that the regulator will find our application more than sufficient.
“This marks the first milestone of many in the commencement of our planned clinical trial, which has the potential to significantly shift the way people utilise psychedelics as an alternative treatment route.
“If approval from Health Canada is obtained, Halucenex will hold another significant competitive advantage and be in a position to commence its clinical trial during Q2 CY2022.
“We are witnessing demand from potential trial participants and making strong progress with our key partners. We look forward to providing additional updates in the coming weeks.”
Phase II clinical trial
The submission of the CTA is an important step in allowing Halucenex to prepare its planned phase II clinical trial to test the efficacy of psilocybin on treatment-resistant PTSD.
It is planned that 18 to 20 individuals (over 19 years old) that suffer from treatment-resistant PTSD will be enrolled in the trial.
Additional work towards trial design and ethics approval has been advanced in collaboration with Acadia University.
Forward plan
Halucenex intends to embark on patient recruitment initiatives following approval from Health Canada, which should allow the company to commence its planned clinical trial during June quarter 2022 with strong demand from potential patients already being witnessed.
The company expects that success in the clinical trial will leave Halucenex well placed to progress a number of potential opportunities in the PTSD therapeutics sector, which is expected to reach a market value of US$10.5 billion by 2025.
Upon completion of the clinical trial, Halucenex will pursue the potential joint venture, licensing, product development and ongoing R&D initiatives.