Clinical-stage biotechnology company PharmAust (ASX: PAA) has engaged UK-based Ergomed Clinical Research to commence clinical trials into the anti-viral effects of lead drug monepantel (MPL) in patients infected with SARS-CoV2, the causative agent of COVID-19.
Ergomed has commenced a feasibility study to identify up to six sites worldwide which are willing to participate in the trial.
The company has shortlisted seven hospitals in five countries, from which it will finalise at least six sites in four countries.
Initial endpoints of the trial include a recommended dose for a phase two study, assessment of adverse events related to MPLS administration; pharmacokinetics of MPL and MPLS, time to sustained resolution or improvement of COVID-19 symptoms, time to progression of COVID-19 symptoms, and reductions in SARS-CoV2 viraemia.
PharmAust said the introduction of a monepantel anti-viral therapy aligns with health policy direction by the Australian government and Nobel Prize laureate Peter Doherty, who claims broad spectrum anti-virals are the world’s future.
High purity specification
PharmAust has focused on developing a high purity specification for MPL tablets, which will be suitable for human and veterinary purposes.
The company has also created a unique manufacturing process to optimise yields, purity and shelf-life stability.
PharmAust chief scientific officer Dr Richard Mollard said Ergomed is working on recruitment feasibility while it finalises the manufacturing process.
“We are expecting the completion of MPL manufacture this week and its subsequent shipment for tabletting,” he said.
“With greater certainty now over the tablet stability, we can provide clinicians and ethics with more precise start dates and will be ready to finalise trial preparations once Ergomed has completed its feasibility exercise.”
In April, PharmAust announced MPL and its metabolite monepantel sulfone (MPLS) could potentially be used as antiviral therapeutics in the prevention and treatment of coronavirus.
The finding has been backed by results from extensive testing of cultured cell infection models of SARS-CoV2 at Leiden University Medical Centre in the Netherlands.