The stability tests marks another key step on PharmAust’s path to commercialisation.

Clinical oncology company PharmAust (ASX:PAA) continues to move towards commercialisation for its lead drug, Monepantel, being developed for the treatment of different types of cancers, viral and neurological diseases.

The company announced results this morning from a 24-month test to monitor the stability of the drug tablets in extended storage.

After two years of storage in a controlled temperature setting of 25°C with 60% humidity, the tablets remained “within specifications relevant for both veterinary and human clinical trials”, PharmAust confirmed.


Ticking the boxes

The stability tests follows on from more good news flow at the end of last month, when PharmAust successfully completed Phase IIa and Phase IIb trials.

The studies showed the application of Monepantel was able to achieve objective tumour regression and increased progression-free survival at a statistically significant level.

In that context, product stability and shelf-life are both important barometers as the company moves towards Phase III trials and commercialisation pathways.

The latest stability study followed two independent tests carried out as part of GMP-approved manufacturing programs.

And the stability of the tablets being used in veterinary work also provides “great confidence” that the next round of PharmAust tablets manufactured for human use will also meet similar specifications,” said PharmAust chief scientific offier Dr Richard Mollard.

“Having a robust GMP tablet significantly reduces costs associated with repeat manufacturing programs and provides certainty for PharmAust’s clinical trial scheduling,” he added.


Clinical trials progressing

PharmAust will be conducting a number of clinical trials commencing later this year as it works to cure cancer in both dogs and humans as well as viral and neurological diseases.

Phase II 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.

Commencement of a human cancer Phase II trial is expected in Q1 CY 2022.

Phase I/II Human Trial in Motor Neurone Disease

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 is expected to begin in the fourth quarter CY 2021.

Phase I/II Human Trial in COVID-19

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.

Commencement of a human COVID-19 Phase I/II trial is expected in Q1 CY 2022.

Phase III Canine Cancer Trial

PharmAust recently made major progress in its quest to commercialise the monepantel  drug for pet dogs with B-cell lymphoma.

Following the treatment of 15 pet dogs during its Phase IIa and Phase IIb studies, the company has successfully achieved the two interim trial primary endpoints: objective tumour regression and increased progression-free survival.

This was achieved by demonstrating sufficient and statistically significant anti-cancer activity in the animals.

The successful outcome will pave the way for the development of Phase III trials and opens the door to explore the value of MPL in other canine cancers.

PharmAust will also seek out leading global pharmaceutical companies as partners to co-develop and commercialise the MPL in a range of veterinary cancers.

It all adds up to another important year for the Perth-based company, which is dual-listed on the ASX (code: PAA) and the Frankfurt Stock Exchange (code: ECQ).

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.