The much anticipated Phase 1 clinical trial of PharmAust’s lead asset Monepantel on patients with Motor Neurone Disease (MND) is about to commence. Image: Getty
Health & Biotech
The much anticipated Phase 1 clinical trial of PharmAust’s lead asset Monepantel on patients with Motor Neurone Disease (MND) is about to commence.
Clinical stage biotech PharmAust (ASX:PAA) is ready to proceed to the all-important Phase 1 clinical trial in MND (Motor Neurone Disease), with tablets of Monepantel expected to arrive at the trial site in Melbourne later this week.
PharmAust made the cGMP (current Good Manufacturing Practice) MPL tablets specifically for the MND trial.
They were designed with a different shape and size, in order to help swallowing by MND patients and to reach specific blood drug levels targeted for this disease.
“It’s a terrific milestone to have MPL tablets designed specifically for this trial on-site,” commented PharmAust’s chief scientific officer, Dr Richard Mollard.
“With the remaining preparations near completion, discussions with potential accruals will be formally commenced once hospital governance is signed.
“We are grateful to FightMND for $881,085 funding for this trial and for its continual support,” he said.
In September last year, charity FightMND pledged $881,085 in funding for PharmAust to examine the effects of its lead drug MPL on MND.
MND or ALS ( Amyotrophic Lateral Sclerosis) 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.
In April, the first $200k instalment was received by PharmAust from FightMND, allowing PAA to make preparations for the current trial.
The second instalment of $99,230 will be payable after the completion of the one-month GMP accelerated stability study of the newly prepared MPL tablets, while the third instalment of $173,034.80 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.
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.
With the cGMP tablets’ imminent arrival, preparations for the trial commencement are mostly complete now, except for some technical and regulatory sign-offs and characterisation of a minor impurity in the tablet – all expected to be finalised prior to the end of May.
When that final hospital governance sign-off is received, recruitment will commence as the Clinical Trials Notification Licence with the Therapeutics Goods Administration (TGA) becomes activated.
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.
