PharmAust sees numerous potential catalysts for next 12 months

PharmAust (ASX:PAA) has announced it will be conducting a half-dozen clinical trials through the second half of next year as it works to cure cancer in both dogs and humans as well as viral and neurological diseases.

In a quarterly update, the Perth-based clinical oncology company detailed a busy corporate calendar as it gets ready for commercialisation of its veterinary drug and talks to clinics in the United States and Eastern Europe about a Phase I trial in humans to treat COVID-19.

PharmAust recently finished its Phase II trial treating six dogs with B-cell lymphoma, the most common canine cancer, with its flagship drug candidate, Monepantel.

Both tumour regression and disease stabilisation was observed, and interim analysis of the trial has provided “further supportive evidence of the monepantel blood plasma levels required to suppress B cell lymphoma growth in pet owners’ dogs,” PharmAust said.

All the pet owners have continued dosing their dogs with the drug now that the study has concluded, the company added.

PharmAust is continuing a Phase IIb dose optimisation trial with current tablets this quarter, to devise the best dosing regimen.

It would then move forward with a Phase III trial in the fourth quarter that could lead to drug approval.

As data emerges, PharmAust plans on talking with leading global pharmaceutical companies about collaborations.

Animal healthcare companies in Germany and the US have already shown interest, approaching PharmAust for discussion. The company has hired former Elanco Animal Health executive Dr Kim Agnew to assist with this process.

Human cancer trial

PharmAust is also talking to global pharmaceutical companies about collaborating to evaluate Monepantel in treating cancer in humans.

The company has identified clinical oncology units in Italy and the United Kingdom to evaluate the company’s new MPL tablet in a Phase II trial.

A Phase I clinical trial held at Royal Adelaide Hospital in 2015 demonstrated suppression of cancer markers, but the “highly unpalatable” liquid formula forced the early stoppage of the study, PharmAust said.

PharmAust has since managed to reformulate the liquid into a tablet that resolves these palatability issues.

COVID-19 Testing

PharmAust is also working towards testing its drug against COVID-19, following promising studies in primate and non-human primates. The company has demonstrated MPL’s antiviral activity in two independent laboratories in Australia and again in the world renowned Leiden University Medical Center (LUMC) in the Netherlands.

GMP-quality production of the tablets has commenced and PharmAust has been engaging with clinicians in the United States as well as Eastern and Caucasus countries and The Balkans about a Phase I trial in human patients to treat COVID-19.

Other activities

PharmAust was previously awarded a $900k grant from FightMND to fund a human trial. FightMND was co-founded by former AFL player and coach, Neale Daniher. The clinical trial will examine the effects of monepantel in motor neurone disease. The Phase I trial will likely begin in the fourth quarter.

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.