The production of its own monepantel (MPL) drug means that PharmAust is now ready to commence human clinical trials of the drugs.

Clinical stage biotech PharmAust (ASX:PAA) announced that it has shipped the first cGMP grade monepantel (MPL) to the US.

This paves the way for the commencement of its planned clinical trials in both motor neuron disease (MND) and COVID-19.

The cGMP (current Good Manufacturing Practice) MPL has arrived in San Diego,  where the formulation and tableting process is already underway.

The smaller size tablets, which will be used for the MND and COVID-19 clinical trials, will have a lower MPL dose per tablet than those for cancer.

PharmAust said the accelerated stability program should enable finished tablets and batch-specific shelf-life data to be available by May, allowing it to commence the MND trial.

“It’s a terrific outcome to produce our own monepantel for use in human studies,” said PharmAust’s Chief Scientific Officer, Dr Richard Mollard.

“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.”

 

The Motor Neurone Disease clinical trial

The Phase 1 trial of MND follows a $880k funding from AFL-linked charity, FightMND.

Founded in 2014, FightMND was established in Australia with the purpose of finding effective treatments and ultimately a cure for MND, also referred to as ALS or Lou Gehrig’s Disease.

It’s a disease in which the nerve cells (neurones) controlling the muscles that enable people to move, speak, swallow and breathe fail to work normally.

The clinical trial will specifically look for signs that MPL can slow the progression of MND.

If effective, MPL could reduce the rate of degeneration and loss of motor neurons in the anterior horns, and motor nuclei of the brainstem for affected patients.

Principal Investigators Professor Dominic Rowe and Dr Sue Mathers will recruit patients and oversee the trial, which will determine whether MPL should go on to be tested in larger Phase 2 studies.

Following today’s development, the MND clinical trial is expected to commence in May.

The COVID-19 trial

Meanwhile, PharmAust has also demonstrated MPL’s antiviral effectiveness in three independent laboratories carrying out both primate and non-primate studies.

In July last year, the company announced that these laboratories have completed examining the effectiveness of MPL  on SARS-CoV2 infection, which is the causal agent of COVID-19 disease.

PharmAust is now keen to see if those remarkable results can be replicated in humans.

PharmAust has engaged Ergomed Clinical Research, a subsidiary of the London Stock Exchange listed Ergomed plc (LON: ERGO) to commence the trials, with the UK-based firm already identifying seven hospitals in five countries eager to host and conduct the trials.

From this list, at least six sites in up to four countries will be selected and finalised.

Ergomed has also set out the primary endpoints for the trials – which include assessing the effect of MPL in reducing  SARS-CoV2 viraemia, as well as determining the dose to use for  a later Phase 2 study.

The trials will then evaluate patient responses and look to describe any improvements from COVID-19 symptoms, and the time it takes to do so.

This article was developed in collaboration with PharmAust, a Stockhead advertiser at the time of publishing.

This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.

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