PharmAust (ASX: PAA) is on track to start a clinical trial of its monepantel (MPL) drug in motor neurone disease (MND) this month following the delivery of tablets to its trial site in Melbourne.
The clinical-stage biotechnology company today reported the arrival of the current Good Manufacturing Practice (cGMP) grade tablets, which were specifically designed with a different shape and size to aid swallowing by MND patients and to reach specific blood drug levels targeted for the disease.
Pre-release technical specifications of the tablets demonstrated that stability specification required for the trial had been achieved. PharmAust is now awaiting signed technical documentation from the manufacturer.
PharmAust said paperwork for the shipment of a back-up second consignment has been completed and these tablets are on route to Melbourne with expected arrival later this week.
Motor neurone disease clinical trial
The clinical trial is being funded with support from FightMND, the largest independent funder of MND research in Australia. Since 2014, the organisation has invested more than $63 million into MND research and care equipment.
In 2020, FightMND committed to fund more than $880,000 to the upcoming clinical study, to be paid in instalments upon PharmAust completing milestones. The last instalment is due once the trial has begun.
In today’s update, PharmAust said auxiliary preparations for the commencement of the MND trial are “mostly complete” with the exception of some technical and regulatory sign-offs and characterisation of a minor impurity in the tablet. All remaining work is expected to be finalised before the end of May.
The company noted that recruitment cannot begin until final governance signature, as this is when the clinical trials notification licence with the Therapeutic Goods Administration (TGA) is activated.
“With the remaining preparations near completion, discussions with potential accruals will be formally commenced once hospital governance is signed,” PharmAust chief scientific officer Dr Richard Mollard said.
PharmAust’s lead drug candidate MPL has previously been evaluated in phase one human clinical trials, where the treatment was found to be well-tolerated and demonstrated preliminary evidence of anti-cancer activity.
The drug has also been evaluated in phase two clinical trials in dogs.