Oncology company PharmAust (ASX: PAA) has narrowed its losses for the full year as it celebrated many achievements in the overall development of its lead cancer drug, monepantel (MPL).
MPL is a veterinary drug registered for use as a wormicide but is being evaluated for its use in cancer therapy for humans and dogs, as well as for the treatment of neurodegenerative diseases including Parkinson’s disease and Alzheimer’s disease.
Preclinical studies have also begun to assess MPL’s use in the treatment of COVID-19 and other related viral infections.
The drug developer today reported preliminary final statements for the year ended 30 June 2020, posting a loss after tax of $1.36 million, a 12% improvement on 2019’s $1.55 million loss.
Group revenue was down 6% to $4.12 million, although revenue from its 100% owned medicinal and synthetic chemistry subsidiary Epichem exceeded expectations at a total of $3.54 million.
“This is in light of the Unity Ltd contract coming to an end sooner than expected and the COVID-19 pandemic,” PharmAust stated.
The pandemic and related shutdown measures put recruitment on hold at some clinics for a phase 2 canine trial being conducted by PharmAust’s wholly-owned cancer therapy subsidiary Pitney Pharmaceuticals.
But as for Epichem, it was the only consortium DNDi Medicinal Chemistry provider that was able to remain open and continue to provide services as many other partners were more seriously impacted and affected by the pandemic.
COVID-19 becomes new drug target
In addition, COVID-19 became a target indication of MPL and preliminary data announced in August demonstrated the molecule can inhibit the progression of the SARS-CoV-2 virus responsible for COVID-19 infections.
One of PharmAust’s research and development targets for the 2021 financial year includes aiming to receive an agreement from a major veterinary company that will enable it to commercially develop an anti-viral MPL-based product against SARS-CoV-2 or COVID-19.
The company also plans to change its current MPL tablet to “create a more tailored human product”, which will permit greater flexibility in dosing to target a wider range of human conditions in addition to cancer, such as COVID-19 viral infections and neurodegenerative disorders.
Then, it plans to have this new tablet evaluated in clinical centres, of which it claimed it is already in talks with several centres and has made “good progress” to date.
PharmAust also intends to begin evaluation of the effects of MPL on preclinical models of neurodegenerative disease and COVID-19 to “understand mechanisms of neuroprotection and anti-viral activity”.
Other MPL triumphs
PharmAust kicked quite a few goals in the last year in the overall development of MPL.
Other achievements include the completion of a phase 2 clinical trial in dogs with cancer that demonstrated anti-cancer activity in MPL tablets, which were at a higher target dose than necessary, meaning subsequent larger scale trials can now target lower dosing.
Collaborative agreements were executed with the University Veterinary Teaching Hospital Sydney (UVTHS), Western Australian Veterinary Emergency and Specialty (WAVES) in Perth and the Animal Referral Hospital (ARH) in Brisbane. These deals enabled a national network of vet clinics to participate in the recruitment of pet dogs for the phase 2 B-cell lymphoma trial.
The company was also awarded several research licences and accreditation to undertake research in Western Australia, Queensland and New South Wales, and completed a second MPL tablet manufacturing round with drugmaker Catalent San Diego in the United States with studies demonstrating the tablets were of high quality and had a long shelf-life.
The road ahead
Along with its COVID-19 drug ambitions, PharmAust has outlined many research and development targets for the next year including plans to evaluate a new MPL tablet for humans in phase 1/2 anti-cancer trials as a follow-on from a 2015 phase 1 clinical trial undertaken at the Royal Adelaide Hospital.
Other plans include undertaking a large “first line therapy” phase 2/3 clinical trial in canines with naturally occurring cancer. This is expected to build on positive outcomes of the recent phase 2 canine trial.
It also aims to secure agreements from vet major/s to commercially develop MPL-based products against motor neurone disease and other central nervous system conditions, as well as SARS-CoV-2.