PharmAust latest report gives green light for continuing trials

PharmAust ASX PAA motor neurone disease Monepantel MPL
PharmAust is on track to start human clinical trials of its drug candidate for patients with motor neurone disease in May.

PharmAust (ASX: PAA) has announced the company is adequately funded to continue its current activities after releasing its March quarter (Q3 FY22) report this week.

The Perth-based clinical stage biotechnology company completed the manufacture of Good Manufacturing Practice (GMP) grade Monepantel (MPL), its lead drug candidate, for human clinical trials during the quarter.

It declared a bank balance of approximately $2.14 million as at 31 March 2022. In addition to this, a FightMND contribution of $200,000 and a $700,000 research and development rebate was received after the end of the reporting period.

Phase I/II human trial in motor neurone disease

During the quarter, PharmAust announced the appointment of Alithia Life Sciences to manage phase 1/2 trial human trials, which will test the safety and tolerability of MPL in patients living with motor neuron disease (MND).

This appointment is fortunately funded through the drug development grant awarded by the FightMND foundation.

Protocols and ethics/regulatory approvals are now in place for MND human trials.

Fortunately for PharmAust, the funding agreement provides that PharmAust will own all intellectual property generated from its phase I/II human trials in MND.

The late May trial start date remains on track with tablet manufacture completed and stability data pending.

The second instalment of the FightMND payments of $99,230 is payable after the completion of the one-month GMP accelerated stability of the newly-prepared MPL tablets which is currently underway.

The third instalment of $173,034 is payable upon commencement of the trial, scheduled for late May 2022.

Phase II canine trials

The March quarter also saw PharmAust make significant developments in canine clinical trials of its primary drug candidate, MPL.

MPL has shown signs of anti-cancer activity throughout stages of phase 2a and 2b trials, allowing the trials to progress.

During the trials, six of the seven dogs treated with drug plasma levels of MPL achieved stable disease of target lesions, with some tumours disappearing completely and minimal to no side effects being detected.

Post-trial, some veterinarians and the respective pet owners have elected to continue MPL treatment, showing positive signs for PharmAust.

PharmAust aims to continue and expand the current trial in Australia, New Zealand and the United States for registration of MPL as an anti-cancer drug in canines with B-cell lymphoma.

As the MPL trials have been such a success, PharmAust continues to take steps to progressing the evaluation of MPL in human trials.

MPL in COVID-19 testing

PharmAust has collaborated with three independent laboratories to uncover if MPL and MPLS have the capacity to protect against cell death.

The results have backed this theory up, with all three laboratories demonstrating that both MPL and MPLS protect against cell death after infection with SARS-CoV2, the causative agent of the COVID-19 virus.

During Q3 FY22, UK-based Ergomed Clinical Research got involved, starting clinical trials testing the anti-viral effects of MPL in individuals infected with SARS-CoV2.

The company has identified a number of hospitals in five countries that are interested in testing the impact of MPL on COVID-19 patients and intends to finalise agreements with several of these.

Positive cash flow during the quarter

Despite the continued uncertainty in global markets, PharmAust believes it is adequately funded to continue its current activities.

During Q3 FY22, payments for R&D reached $180,000 to help develop MPL as well as salary allocations to Dr Richard Mollard.

Cash outflows for the quarter were in line with what PharmAust management anticipated.

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