PharmAust’s clinical trials of monepantel in dog cancer, COVID-19 and motor neurone disease are all expected to start in May 2022, with human cancer anticipated to commence Q4 CY 2022.
Clinical stage biotech PharmAust (ASX:PAA) has provided a quarterly update, confirming progress made on a number of clinical trials studying flagship drug monepantel (MPL).
The company is moving towards a Phase 3 clinical trial for canines with lymphoma, having just expanded its studies into New Zealand during the quarter.
Data from Phase II showed that combining MPL with prednisolone more than doubles the life expectancy of pet dogs, compared with standard-of-care (prednisolone alone).
This data supports the continued development of the canine clinical trial into registration trials this calendar year.
Preparations for a Phase II human trial focusing on glioblastoma, esophageal, gastrointestinal and pancreatic cancers is also underway.
For this trial, PharmAust has identified Principal Investigators in Italy and the UK to evaluate the new MPL tablet for the Phase 2 trials, as a follow-on from the Phase I clinical trial conducted at the Royal Adelaide Hospital in 2015.
The Phase 2 human trial is expected to commence in Q4 of this year.
A previously announced funding commitment of around $900k for a Phase I/II trial examining the effects of MPL in Motor Neurone Disease (MND), otherwise known as Lou Gehrig’s disease or Amyotrophic Lateral Sclerosis (ALS), will commence around May 2022.
The funds were granted by FightMND, the largest independent funder of MND research in Australia.
More protection
Previously, a collaboration with three independent laboratories has investigated the capacity of MPL and metabolite monepantel sulfone (MPLS) on SARS-CoV2 infection, which is the causal agent of COVID-19 disease.
All three laboratories demonstrated that both MPS and MPLS protect against cell death in-vitro, following infection with SARS-CoV2.
PharmAust are keen to see if the remarkable results can be replicated in humans. Trial sites to participate in the evaluation of tablet formulated MPL in COVID-19 are currently being identified by the Company’s CRO partner in Europe.
On the balance sheet front, PharmAust finished the quarter well funded, with a cash position of $2.64 million which it says can be used to fund all of its current activities.
Extension of anti-viral studies
For the COVID-19 trial, PharmAust has successfully completed primary diligence on potential trial sites with six centres expressing interest.
The company is now preparing trial design, while engaging local contract research associates to assist running the trial sites using an appropriate monepantel study protocol.
To further the anti-viral application of MPL, PharmAust executed a Research Services Agreement with the Walter and Eliza Hall Institute (WEHI) in Melbourne to investigate the effects of the drug on human T-lymphotrophic virus-1 (HTLV-1) infections in vitro.
This work follows upon the COVID-19 program, and aims to further understand the anti-viral activity of MPL and to broaden the scope of targets for MPL’s use.
The study of HTLV-1 is of particular significance due to the readily available nature of highly and particularly relevant in vitro and in vivo preclinical virus infection models, potentially providing PharmAust with further data to support future human trials.
Epichem’s disruptive technology
In August last year, PharmAust announced that its wholly-owned subsidiary, Epichem, had reached a critical milestone in developing its disruptive waste-to-fuels technology.
The company 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.
An e-waste grant was approved by the WA Government New Industries Fund WasteSorted to support this project.
In December, Epichem was also awarded an extension to its current contract with Drugs for Neglected Diseases initiative (DNDi).
The contract renewal will see Epichem continue to provide its synthetic and medicinal chemistry expertise to support DNDi’s drug discovery projects until December of 2022, which is expected to generate up to $1.02m in revenues.
DNDi is funded by the Bill & Melinda Gates Foundation as well as other private foundations and individuals.
To push these initiatives forward, Epichem made a strategic appointment during the quarter, hiring Dr Gary Pitt as its new Head of Chemistry.
Dr. Pitt brings more than 20 years’ experience in drug discovery and development within the pharmaceutical industry and academia, in both the UK and Australia.
Manufacturing of GMP-grade MPL tablets
Production is underway for two batches of 10kg each of GMP-grade MPL for research and development (R&D) purposes and clinical trials in humans.
The GMP-grade MPL compound is being manufactured in collaboration with Syngene International, an integrated research, development and manufacturing services company, and Catalent Pharma Solutions (NYSE: CTLT).
A total of 2,000 demonstration batch tablets were successfully produced using the same process used to produce the previous larger tablets.
The smaller size tablets, which will be used for the upcoming motor neuron disease (MND) and COVID-19 clinical trials, will have a lower MPL dose per tablet than those for cancer.
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.
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