Clinical-stage biotechnology company PharmAust (ASX:PAA) has announced that after formally testing monepantel tablets for 24 months in storage at a controlled temperature of 25°C with 60 per cent humidity, the tablets remain within specifications relevant for both veterinary and human clinical trials.
The company said this is after two independent GMP-grade stability studies from two independent GMP manufacturing programs. Tablet stability data result from periods of up to 24 months and 19 months storage from these two independent programs.
According to chief scientific officer Dr Richard Mollard, “The stability data for the tablets currently being used for veterinary work provides great confidence that the next round of GMP tablets manufactured for human testing will similarly meet required specification levels. Having a robust GMP tablet significantly reduces costs associated with repeat manufacturing programs and provides certainty for PharmAust’s clinical trial scheduling.”