PharmAust commences manufacture of monepantel tablets

PharmAust ASX PAA commences manufacture monepantel tablets MPL motor neurone disease coronavirus
PharmAust's monepantel tablets are being manufactured ahead of a motor neurone disease clinical trial in May.

Australian clinical-stage biotechnology company PharmAust (ASX: PAA) has commenced the manufacture of monepantel tablets to enable clinical trials into motor neurone disease and coronavirus.

The company shipped the current Good Manufacturing Practice (cGMP) grade tablets to the US, with the tableting process underway in San Diego.

PharmAust has developed a manufacturing process to optimise yields, purity and shelf-life stability.

Release of finished tablets and batch-specific shelf-life data is expected to enable the start of a motor neurone disease clinical trial in May.

PharmAust chief scientific officer Dr Richard Mollard welcomed the manufacturing milestone.

“It is a terrific outcome to produce our own monepantel for use in human studies,” he said.

“Now that we have a defined process for producing scalable GMP material, [we] will commence planning a further manufacturing round to supply monepantel for cancer and other trials in humans.”

FightMND grant

In late 2020, PharmAust received an $880,000 funding commitment from FightMND for a phase one trial into the effects of monepantel on motor neurone disease – also known as Lou Gehrig’s disease or amyotrophic lateral sclerosis (ALS).

The trial will test the safety and tolerability of monepantel in motor neurone patients and look for signs that the drug can slow the progression of the disease.

The data, in conjunction with concurrent animal studies, will determine whether monepantel should be tested in larger phase two studies.

FightMND is the largest independent funder of motor neurone research in Australia and is due to pay the first instalment of approximately $200,000 after GMP manufacture of monepantel for the trial has been completed.

COVID-19 trials

Last month, PharmAust announced it had engaged UK-based Ergomed Clinical Research to commence trials into the anti-viral effects of monepantel in people infected with the SARS-CoV2, which is the causative agent of COVID-19.

Ergomed has already identified seven hospitals in five countries which have shown an interest in testing the effects of monepantel upon COVID-19 patients.

The company will finalise at least six sites in up to four countries.

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