Clinical-stage biotechnology company PharmAust Limited (ASX: PAA) has successfully shipped cGMP (current Good Manufacturing Practice) grade monepantel (MPL) to the US, with the tableting process underway in San Diego.
Completion of the manufacture of cGMP grade MPL tablets will enable commencement of both motor neuron disease and COVID-19 clinical trials.
Chief Scientific Officer, Dr Richard Mollard, said availability of finished tablets and batch-specific shelf-life data will enable a May commencement of the motor neuron disease clinical trial.
“It is a terrific outcome to produce our own monepantel for use in human studies. Now that we have a defined process for producing scalable GMP material, PharmAust will commence planning a further manufacturing round to supply monepantel for cancer and other trials in humans.”
PAA’s lead drug candidate is monepantel (MPL), a novel, potent and safe inhibitor of the mTOR pathway – a pathway having key influences in cancer growth and neurodegenerative diseases. MPL has been evaluated in Phase 1 clinical trials in humans and Phase 2 clinical trials in dogs.
MPL treatment was well-tolerated in humans, demonstrating preliminary evidence of anticancer activity. MPL demonstrated objective anticancer activity in dogs. PAA is uniquely positioned to commercialise MPL for treatment of human and veterinary cancers as well as neurodegenerative disease as it advances a reformulated version of this drug through Phase 1 and 2 clinical trials.