PharmAust’s appointment of UK-based Ergomed means that it’s now in a position to start on the COVID-19 clinical trial of monepantel in the coming months.
Clinical stage biotech PharmAust (ASX:PAA) has broken new ground on the planned clinical trial of its lead drug montepantel (MPL), which has shown enormous early potential in the treatment of people infected with SARS-CoV-2 – the virus behind COVID-19.
PharmAust has engaged Ergomed Clinical Research, a subsidiary of the London Stock Exchange listed Ergomed plc (LON: ERGO) to commence the trials, with the UK-based firm already identifying seven hospitals in five countries eager to host and conduct the trials.
From this list, at least six sites in up to four countries will be selected and finalised.
Remember the data: May 2022
Ergomed has also set out the primary endpoints for the trials – which include assessing the effect of MPL in reducing SARS-CoV2 viraemia, as well as determining the dose to use for a later Phase 2 study.
The trials will also study the pharmacokinetics of MPL and MPLS (metabolite monepantel sulfone), and assess any adverse events related to the MPLS administration.
The trials will then evaluate patient responses and look to describe any improvements from COVID-19 symptoms, and the time it takes to do so.
“We’re expecting the completion of MPL manufacture this week and its subsequent shipment for tabletting,” PharmAust’s Chief Scientific Officer, Dr Richard Mollard said.
“Accelerated tablet stability data are expected to be available in May 2022 followed by treatment of COVID-19 patients,” he said.
Broad-spectrum antiviral therapy is the future
PharmAust’s strategy to introduce MPL as an antiviral therapy aligns with the direction preferred by Nobel Prize laureate Peter Doherty, as well the Australian Health Minister Greg Hunt.
In an article published by the AFR in January, Minister Hunt said that in the past, common antibacterial therapies have managed dangerous infections. And now, a similar response is needed to counter rapidly spreading viruses.
“Professor Doherty’s advice to me was that broad-spectrum antivirals are the world’s future in this space, and that research investment is fundamental,” Minister Hunt told the AFR.
According to Doherty, broad-spectrum antivirals include drugs targeting host-cell machinery essential for virus infection and replication, as well as drugs designed to target viruses directly.
The Minister’s direction suits PharmAust perfectly; the Aussie-listed biotech firm is already testing the MPL drug in multiple viral diseases starting with COVID-19.
Previous collaborations with three independent laboratories have demonstrated that both MPS and MPLS protect against cell death in-vitro, following infection with SARS-CoV2.
PharmAust is now keen to see if those remarkable results can be replicated in humans.
“With greater certainty now over the tablet stability, we can now provide clinicians and ethics with more precise start dates and will be ready to finalise trial preparations once the Ergomed feasibility exercise is completed,” said Dr Mollard.
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.