Creso Pharma Ltd (ASX:CPH, OTCQB:COPHF) subsidiary Halucenex Life Sciences Inc will expand the scope of Phase 2 clinical trials assessing the efficacy of psilocybin on treatment-resistant Post Traumatic Stress Disorder (PTSD).
If the amendment to the trial’s Clinical Trial Authorisation (CTA) is granted by Health Canada, Halucenex will be able to include cohorts being treated with Selective Serotonin Reuptake Inhibitors (SSRIs) without requiring these patients to cease their prescribed medications a week prior to the trial.
A broadened CTA would provide Halucenex with more comprehensive trial data and allow a larger spectrum of patients to participate, gaining valuable insight into how psilocybin interacts with other medications.
As part of its preparation for the Phase 2 trial, Halucenex has appointed KGK Science Inc as contract research organisation to provide additional expertise, and neurologist Dr Gosia Eve Phillips, MD, DABPN as principal investigator.
Potentially “ground-breaking” research
“In the recent months, Halucenex has made considerable progress towards the commencement of what has the potential to be a ground-breaking research initiative," Halucenex CEO and founder Bill Fleming said.
“We have been completely inundated from several groups regarding potential participation in the study, highlighting the demand for an alternative treatment solution to pharmacological interventions.
“Further, by lodging an application to extend the scope of our CTA, we are expecting benefits from the additional data that the broadened scope will provide, including observing how psilocybin interacts with other medication being used as treatment for PTSD.
“We are confident that the appointment of both KGK and Dr Phillips will also be beneficial for the company.
“KGK has extensive experience with pharmaceutical drug testing and development and provides a much more cost-effective service offering.
“The appointment of someone as esteemed as Dr Phillips is also a great development for Halucenex. We look forward to working with both parties in the coming weeks.
“The board and management will continue working with the independent ethics board and Health Canada for final approvals and expect additional updates to materialise shortly.”