Following a successful phase IIa trial using monepantel (MPL) to treat canine lymphoma, PharmAust’s (ASX: PAA) phase IIb study has begun.
The recent phase IIa trial using monepantel to treat B-cell lymphoma in canines resulted in tumour regression and stable disease.
“PharmAust is pleased to recommence this trial using MPL tablets to treat pet owners’ dogs with B-cell lymphoma,” PharmAust chief scientific officer Dr Richard Mollard said.
“PharmAust has been testing two independent hypotheses: firstly, that MPL tablets could make cancer disappear and, secondly, that MPL tablets could stop cancer progressing (stable disease).”
In the upcoming phase IIb research, Dr Mollard said the company will focus on optimising the dosing regimen to maximise MPL’s anticancer activity.
Results from this study will underpin phase III research that is scheduled to begin in the latter half of the year.
Additionally, PharmAust is in discussions with animal healthcare companies regarding identifying cancers to target commercially with MPL.
Monepantel tablet manufacture for human trials
During the December 2020 quarter, PharmAust began manufacturing 10kg of MPL tablets for upcoming human trials and research.
Previous human studies showed prevention of tumour progression using a liquid MPL formulation. However, the trial was stopped early due to the “unpalatable” nature of the liquid.
To resolve the palatability issues, PharmAust reformulated MPL into a tablet.
The human cancer phase II trail is scheduled to begin early next year.
Meanwhile, further preclinical research is ongoing in collaboration with the Olivia Newton-John Cancer Research Institute.
“PharmAust is looking forward to seeing at the molecular level how MPL works in cells to combat disease, especially in terms of how MPL’s mechanism of action differs to other mTOR inhibitors presently in the clinic,” Dr Mollard said.
Monepantel in other conditions
As well as using MPL to treat cancer, PharmAust is investigating the impact of MPL in other conditions including COVID-19.
During the December quarter, PharmAust inked a deal with Netherlands’ researchers to evaluate the impact of MPL and monepantel sulfone on SARS-CoV-2 in cells.
A final report from the research is “imminent”.
PharmAust noted MPL may have a “distinct advantage” over other drugs in development for treating the virus because it has already been used in human trials and has a “high” safety profile.
Additionally, the only other currently approved treatment remdesivir requires intravenous administration, whereas MPL can be given in tablet form.
“This means patients could be treated earlier when they first test positive rather than intensive care patients hospitalised with COVID-19,” the company added.
PharmAust is also looking at treating motor neurone disease with MPL.
The company has begun preparing for a phase I trial with recruitment to begin “as soon as possible”.
PharmAust’s wholly owned subsidiary Epichem continued to build its own IP portfolio during the December quarter.
This included executing a heads of agreement to develop and commercialise a biomass/feedstock oxidative process that can convert waste into fuels.