PharmAust (ASX:PAA) says it will undertake an interim analysis of preliminary biomarkers and efficacy markers on completion of dosing of the last patient of Cohort 2 in its motor neurone disease trial of Monepantel (MPL).
The company said the interim analysis constitutes an approved protocol amendment to the initially approved protocol as recommended by the principal investigator.
Treatment-related changes from baseline in this safety, tolerability, pharmacokinetic and preliminary, efficacy study will include an analysis of functional rating scales, quality of life and cognitive assessment. Prognostic indicators and several disease-related biomarkers will also be measured.
PharmAust said following this protocol amendment, it will continue with the MPL dose escalation for Cohorts level 3 and then 4, subject to Safety Committee reviews.
PharmAust executive chairman, Dr Roger Aston said, “Subject to trial outcomes under this protocol amendment, PharmAust expects to prepare the ground for the MND trial to be expedited into Phase 2. The protocol amendment and interim analysis has been recommended by the Principal Investigator.
"PharmAust will also continue with the MPL dose escalation for Cohorts 3 and 4 during the interim trial analysis to determine the optimum dose level for the Phase 2 trial.”