- PharmAust (PAA) receives its first monepantel (MPL) tablets specifically designed for the Phase I motor neuron disease (MND) trial in Melbourne
- The current Good Manufacturing Practice (cGMP) grade MPL tablets are designed with a different shape and size to help swallowing by and to reach specific blood drug levels
- Final technical and regulatory sign-offs, including “characterisation of a minor impurity in the tablet”, are expected by the end of May
- Recruitment will commence once the the final governance signature is given which will activate the Clinical Trials Notification Licence with the TGA
- PharmAust shares finished trading last week at 9 cents each
PharmAust (PAA) has received its first monepantel (MPL) tablets specifically designed for the Phase I motor neuron disease (MND) trial in Melbourne.
The current Good Manufacturing Practice (cGMP) grade MPL tablets were designed with a different shape and size to help swallowing by MND patients and to reach specific blood drug levels targeted for the disease.
Completed paperwork for shipment of the contingency second consignment of MPL tablets are on route with expected arrival later this week.
“With the remaining preparations near completion, discussions with potential accruals will be formally commenced once hospital governance is signed,” Chief Scientific Officer Dr Richard Mollard said.
Auxiliary preparations for the MND trial commencement are near completion except for some technical and regulatory sign-offs, and “characterisation of a minor impurity in the tablet.”
The final preparations are expected to be finalised prior to the end of May.
Recruitment, however, cannot commence until the final governance signature as this is when the Clinical Trials Notification Licence with the Therapeutics Goods Administration (TGA) becomes activated.
Pre-release technical specifications of the MPL tablets proved that stability specification required for the trial was achieved.
The company awaits signed technical documentation from the manufacturer.
PharmAust recently received the first instalment of its $881,085 funding from FightMND for the Phase 1 trial, which Dr Mollard said the company was “grateful for the continued support”.
PharmAust shares finished trading last week at 9 cents each.