After completing MPL demonstration batch manufacture, PharmAust is now preparing for clinical trials of its lead drug Monepantel in COVID-19 and Motor Neurone Disease treatments.

Clinical stage biotech company, PharmAust (ASX:PAA) is making further advances for the use of its lead drug, Monepantel (MPL) in COVID-19 and Motor Neurone Disease (MND) human clinical trials.

PharmAust has announced the 500g demonstration batch of MPL generated shows a greater purity profile than the previous Good Manufacturing Practice (GMP) batches used in the Phase 1 trial in humans and the Phase 2a and 2b trials in pet dogs with B cell lymphoma.

The demonstration batch has now arrived in the US for the preparation of the new smaller tablet design for use in the MND and COVID-19 trials in humans.

Success in the manufacture of this demonstration batch means that PharmAust is now in the process of scaling up a GMP batch ready for the COVID-19 and FightMND-funded trials due to start around April 2022.

PharmAust is in final negotiations with organisations that will provide the necessary MND trial services including clinical oversight, regulatory oversight, monitoring, pharmacokinetic analysis and pharmacodynamic analysis.

PharmAust has undertaken a preclinical program on the effects of MPL on SARS-CoV-2 virus  infection and replication.

PharmAust’s chief scientific officer Dr Richard Mollard said the company could now confidently negotiate with Contract Research Organisations to identify trial sites for testing MPL in people infected with SARS-CoV-2, the virus causing COVID-19.

“Despite the delays incurred in manufacture due to the global COVID-19 pandemic, PharmAust remains on track to recommence clinical trials in humans with a newly designed tablet, suitable for dosing regimens in people with Covid-19 and motor neurone disease,” Mollard said.

PharmAust developing therapies for both humans and animals

PharmAust is a clinical-stage company developing therapeutics for both humans and animals. The company specialises in repurposing marketed drugs lowering the risks and costs of development.

The company is supported by its subsidiary, Epichem, a highly successful contract medicinal chemistry company that generated $2.2 million in revenue in FY 2021.

PharmAust’s lead drug MPL is a novel, potent and safe inhibitor of the mTOR pathway – a pathway having key influences in cancer growth and neurodegenerative diseases.

MPL has also shown promising results in the treatment of canine cancer.  PharmAust recently announced preparation for a Phase 3 trial for MPL in dogs with B-cell lymphoma, following encouraging results in the Phase 2 study.

Data from the Phase 2 trial has shown that combining MPL with prednisolone more than doubles the life expectancy of pet dogs, compared with standard-of-care (prednisolone alone).

With the current price of canine chemotherapy being prohibitively expensive,  PharmAust believes that subject to Phase 3 results, MPL could be a commercially compelling alternative treatment.


The mission to provide effective treatments for MND

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.

Motor Neurone Disease is the name given to a group of diseases in which the nerve cells (neurones) controlling the muscles that enable people to move, speak, swallow and breathe fail to work normally and eventually die.

With its vision of a world without MND, FightMND is the largest independent funder of MND research in Australia and has invested more than $63 million into research and care equipment to improve the lives of those fighting the disease.

At the time of writing the PharmAust share price was up 3.09% to 10 cents.

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.