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- Creso Pharma’s (CPH) subsidiary, Halucenex Life Sciences, secures an amendment to its Clinical Trial Authorisation (CTA) from Health Canada
- This marks a key step in commencing a phase two clinical trial testing the efficacy of Halucenex’s psilocybin drug on treating resistant PTSD
- The amendment means patients using other PTSD medication may participate in the trial rather than having to stop taking prescribed medications a week before the trial starts
- Subject to ethics approval, the company expects to administer the first dose in September
- CPH shares are trading down 2.63 per cent to 3.7 cents at market close
Creso Pharma’s (CPH) subsidiary, Halucenex Life Sciences, has secured an amendment to its Clinical Trial Authorisation (CTA) from Health Canada.
The amendment marks a key step in proceeding to the commencement of Halucenex’s phase two clinical trial to test the efficacy of its psychedelic drug, psilocybin, in treating resistant post traumatic stress disorder (PTSD).
The amended CTA essentially allows patient cohorts using other medication associated with managing PTSD symptoms to participate in the trial, instead of having them stop using prescribed medications for a week before the trial begins.
The Canadian psychedelics subsidiary said this change will allow it to generate additional data around psilocybin use alongside other pharmalogical treatments.
CPH CEO and Managing Director William Lay said the amendment is a “major step forward” for Creso Pharma, Halucenex and patients managing PTSD symptoms while using other medication.
“This clinical trial has the potential to unlock a new and natural alternative to current pharmacological treatments used by PTSD sufferers, while unlocking a new market for the company,” Mr Lay said.
Final submissions have been made to the Ethics Review Board and the outcome is expected shortly. Once it receives ethics approval, Halucenex expects to begin administering first doses under the phase two trial in September.
CPH shares were trading down 2.63 per cent to 3.7 cents at market close.
