With four clinical trials kicking off, PharmAust is set for a busy 2022

PharmAust’s clinical trials of monepantel in canines, COVID-19 and motor neurone disease are all expected to start in May 2022, with human cancer anticipated to commence Q3/4 CY 2022.

Clinical stage biotech, PharmAust (ASX:PAA), has been busy pushing forward with a number of clinical trials studying its lead drug, monepantel (MPL).

The company has three parallel clinical trials of MPL that are about to commence – a Phase 3 trial in canines with B-cell lymphoma, and two Phase 1 human trials for motor neuron disease (MND) and COVID-19.

All three trials are expected to commence in May 2022 whilst commencement of a human cancer Phase II trial is expected in Q3/4 CY 2022.

Meanwhile, its wholly owned subsidiary, Epichem, continues to advance its disruptive waste conversion and re-purposing technology, Oxidative Hydrothermal Dissolution (OHD).

Epichem is currently undertaking a R&D project grant provided by the WA government to progress the conversion of e-waste into energy by using the OHD technology.

Phase 3 trial in canines moving swiftly

Following the Phase 2 study of MPL tablets in canines with B-cell lymphoma, PAA has now moved toward a registration of a Phase 3 trial.

Plans are to conduct the Phase 3 study in Australia, New Zealand and the US.

Data from the Phase 2 trial to date has demonstrated MPL’s anticancer activity in canines with B-cell lymphoma.

Post-trial, some veterinarians and pet owners have even elected to continue MPL treatment, and sometimes in combination with prednisolone.

This combination has provided an average extension of survival to these pet dogs of 16-24 weeks, which compare favourably to a 6-8 week survival using standard care (palliative steroid therapy).

According to PharmAust, canines treated with MPL during and after the trial experienced a better quality of life, with minimum adverse events being reported.

These canine outcomes bode well for further human cancer trials that PharmAust is expected to pursue in CY 2022.

Toward a Phase 1 trial in MND and COVID-19

In the human trials of MPL, PharmAust is targeting evaluation in two clinical trial settings: MND and COVID-19.

The Phase 1 trial of MND follows $880k funding from AFL-linked charity, FightMND.

The study will specifically look for signs that MPL can slow the progression of MND – a condition that became widely known following the affliction of renowned physicist, Stephen Hawking.

If effective, MPL could reduce the rate of degeneration and loss of motor neurons in the anterior horns, and motor nuclei of the brainstem for affected patients.

Principal Investigators Professor Dominic Rowe and Dr Sue Mathers will recruit patients and oversee the trial, which will determine whether MPL should go on to be tested in larger Phase 2 studies.

Meanwhile, PharmAust has also demonstrated MPL’s antiviral effectiveness in three independent laboratories carrying out both primate and non-primate studies.

In July, the company announced that these laboratories have completed examining the effectiveness of MPL on SARS-CoV2 infection, which is the causal agent of COVID-19 disease.

For the upcoming COVID-19 Phase 1 trial, PharmAust has successfully undergone primary diligence on potential trial sites, with six centres now expressing interest.

The company is now preparing the trial design, while engaging local contract research associates to assist running the sites using an appropriate MPL study protocol.

GMP manufacturing of MPL tablets for both the FightMND and COVID-19 trials is progressing well, with MPL shipment now expected for tablet manufacture in January 2022.

This is three weeks later than previously anticipated, due to the detailed requirements for provision of the necessary standards of Phase 3 GMP goods.

In the meantime, demonstration batch tablet manufacture for the smaller size tablets has been successfully completed, with stability testing started.

GMP tablet manufacture is booked for the second week of February, and both trial start dates are anticipated for early May 2022.

Phase II Human Cancer Trial

PharmAust continues to take key steps towards progressing the evaluation of MPL in human trials, as a follow on from the Phase I clinical trial undertaken at the Royal Adelaide Hospital in 2015.

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, and to discuss the optimal type of cancers to target.

Clinical interest has focused on glioblastoma, esophageal, gastrointestinal and pancreatic cancer.

The company says it will continue to look for further sites to broaden recruitment possibilities, with commencement of a human cancer Phase II trial expected in Q3/4 of CY 2022.

Epichem’s disruptive technology

In early August, PharmAust announced that its wholly-owned subsidiary, Epichem, had reached a critical milestone in developing its disruptive waste-to-fuels technology.

Epcihem had completed building the world’s first flow reactor using the benchtop Oxidative Hydrothermal Dissolution (OHD) technology, which could turn a wide range of waste and biomass feedstock into valuable energy products.

This technology has the potential to take Epichem and parent PharmAust into the bioplastics and bio-ethanol energy markets, expected to be worth $70 billion by 2028.

To progress the technology into commercialisation, Epichem is currently undertaking a WA Government e-waste grant project, designed to test the technology.

The grant funding will see Epichem showcase the use of its OHD technology to convert e-waste into useful end products, recover valuable metals and produce useful high value chemicals.

The R&D program will also support a new and innovative solution to process collected e-waste, and reduce the amount of e-waste ending up in landfill.

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.