The much anticipated Phase 1 clinical trial of PharmAust’s lead asset monepantel on patients with Motor Neurone Disease (MND) will finally commence.

Clinical stage biotech PharmAust (ASX:PAA) is set to commence the Phase I clinical trial for  people with motor neurone diseases (MND), following the receipt of the first $200k instalment grant from FightMND.

In September last year, charity FightMND pledged $881,085 in funding for PharmAust to examine the effects of its lead drug monepantel (MPL) on MND, otherwise known as Lou Gehrig Syndrome or Amyotrophic Lateral Sclerosis (ALS).

The first instalment or milestone was dependent on PharmAust completing the manufacture of cGMP (current Good Manufacturing Practice) grade MPL.

The second instalment of $99,230 will be payable after the completion of the 1-month GMP accelerated stability study of the newly prepared MPL tablets, which is currently underway.

The thirdl instalment  of $173,034.80 meanwhile, will be payable upon commencement of the trial itself. Further instalments for a total commitment of $881,085 will be paid by FightMND to PharmAust as they hit additional milestones during the clinical trial.

Founded in 2014 by former AFL player and coach Neale Daniher,  FightMND is a charity established with the purpose of finding effective treatments and a cure for MND.

MND or ALS is the name given to a group of diseases that affect nerve cells controlling our everyday movements including breathing.

It became widely known following the affliction of the late renowned physicist, Stephen Hawking.

The disease is rare and invariably fatal, with the average life expectancy of someone who has MND being just 27 months.

PharmAust engages Alithia Life Sciences

PharmAust has engaged the services of Alithia Life Sciences Pty Ltd to manage the Phase  clinical trial.

Alithia will provide project and site management, and support of the planned study. The appointment is fully funded through the grant awarded by FightMND.

“PharmAust is delighted to make this appointment to work with the highly experienced personnel at Alithia,” says PharmAust CEO, Dr Richard Mollard.

“We look forward to trial commencement and providing positive outcomes for people enrolled in the clinical trial”.

The Phase I clinical trial

According to a previous release from PharmAust, the Phase I clinical trial is designed to test the safety of using MPL in 12 individuals living with ALS/MND.

The patients will undergo dosing according to a conventional dose escalation design, with each level of the dose escalation lasting 28 days.

Measures of efficacy will also be included in the trial, so it can be extended into a Phase II setting when appropriate.

The late May trial start date remains on track, with tablet manufacture completed and stability data pending.

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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