Biotechnology company PharmAust (ASX: PAA) has updated the market on its range of clinical trials relating to its lead drug candidate monepantel (MPL).
The company’s manufacturing program includes production of the drug’s active pharmaceutical ingredient (API) at an Indian facility; and creating tablets of MPL and conducting stability and purity analysis in the US.
PharmAust confirmed the program has been completed and it is ready to proceed with human trials of MPL on patients with motor neurone disease (MND).
The trial will test the safety and tolerability of the drug and identify any signs which indicate it may be capable of slowing the disease.
Tablets for use in the trial have been designed with a different shape and size to aid swallowing by MND patients and to reach specific blood drug levels targeted for the disease.
The tablets were made to current good manufacturing practices (cGMP) and shipped to Sydney and Melbourne earlier this month.
PharmAust confirmed the batch had passed all required stability and formulation testing.
The clinical trial is being funded with support from FightMND, which is 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 $881,085 to the trial and paid an initial instalment of approximately $201,615, which was dependent on PharmAust completing the first milestone.
The second instalment of $99,230 is now payable to PharmAust after completion of the one-month accelerated stability testing of the newly-prepared monepantel tablets.
The third instalment of the grant ($173,035) will be payable upon commencement of the trial.
PharmAust said work was on track to complete preliminary trial formalities this month, with patient recruitment to begin in June.
PharmAust has been identifying clinical centres capable of sourcing patients with the required COVID-19 progression and vaccination status for its phase 2 human study into the effects of MPL on the virus.
The search has focused on countries within the Eastern Bloc where there remains a significant number of unvaccinated patients.
Three clinical centres in Romania and Bosnia have expressed interest in recruiting sufficient numbers of suitable patients for the trial.
PharmAust has confirmed it will use phase 1 MND trial pharmacokinetic data for the COVID-19 work.
The company said the move would facilitate faster recruitment and a financial saving of around $1.5 million.
In a related development, PharmAust has signed an agreement to evaluate MPL in transgenic “humanised” mice, in an effort to express the receptors that the COVID-19 virus binds to in humans.
The company said efficacy in this anti-viral model would provide further evidence of the anti-viral effects of MPL.