PharmAust opens door to billion-dollar markets, following MPL trial successes
PharmAust has produced 2,000 anti-cancer monepantel tablets for the phase I clinical trial in dogs, which is scheduled to begin on 19 February.
PharmAust (ASX: PAA) could soon open the door to billion-dollar drug success opportunities after recent positive developments through testing and trials on its primary lead drug candidate monepantel (MPL).
The Perth-based clinical stage biotechnology is focused on repurposing the drug MPL for multiple targeted therapeutics in humans and animals, with several clinical trials set to commence in the 2023 financial year.
MPL is novel, potent and non-toxic inhibitor of the mammalian target of rapamycin (mTOR) pathway, which is key in influencing cancer growth, neurodegenerative diseases and even viral activity.
The global mTOR inhibitor currently exceeds US$2.5 billion (A$3.57 billion) annually and PharmAust is aiming to cash in on MPL’s use in veterinary cancers as well as human cancers in the future.
Unlike chemotherapy and rapamycin alternatives, MPL contains a non-toxic nature which protects the individual’s immune system from obliteration, allowing for high MPL dosages, resulting in better quality of life prospects.
PharmAust claims its anti-cancer properties also propose a cheaper and ethical alternative to chemotherapy in canines, as demonstrated by data to date from the company’s phase 2 trial.
Repurposing MPL
While chemotherapy has been the traditional method to fight against cancer, it also targets regular healthy cells, while trying to fight harmful cells, harming the body’s immune system.
As a result though mTOR inhibitors are effective in preventing cancer cell growth and proliferation, they can attack healthy tissues simultaneously with cancers.
PharmAust say MPL can act as a pivotal anti-cancer therapy, suffocating targeted cancers over extended periods of time, safely and with good quality of life outcomes.
MPL also promotes autophagy, which works towards preserving the body’s healthy cells, including the cleaning up of dying cancer cells.
MPL contains an almost completely non-toxic nature, provides a significant advantage over existing oncological, and offers neurodegenerative therapies.
As a repurposed drug, MPL is currently registered in 38 countries as well as being approved by the Therapeutic Goods Administration (TGA) in Australia.
Repurposed drugs control the veterinary market and are increasing in popularity for human products as they are cost and time effective in comparison to other drugs.
MPL has a positive history as a repurposed drug, in both humans through clinical trials and animals, through Zolvix.
MPL canine cancer therapy
Canines suffer from many of the same cancers as humans due to similar gene systems.
MPL is registered in 38 countries for use in animals.
PharmAust’s phase 2 trials in canines with B-cell lymphoma demonstrated positive anti-cancer activity and increased progression-free survival by MPL.
Global pharmaceutical players, also known as ‘Big Pharma’ have shown interest in a MPL licencing or sales opportunities as a result of the promising signs.
PharmAust’s canine results are also being recognised internationally, with clinical interest from the United Kingdom, Italy and the United States involving focused phase 1/2 human trials in leukaemia, glioblastoma, oesophageal, gastrointestinal, ovarian and pancreatic cancers.
MND phase 1 clinical trial leads to COVID-19 phase 2 trials
MPL induces autophagy, which is a mechanism that clears unprocessed and excessive intracellular protein in neural cells associated with the cause of amyotrophic lateral sclerosis (ALS) and motor neurone disease (MND).
PharmAust believes MPL can benefit patients’ neural cells by regulating these proteins and possibly reducing the symptoms.
The company’s phase 1 MND trial will provide important pharmacokinetic data for both MND and COVID-19 trials, allowing PharmAust to skip to a phase two study in COVID-19.
PharmAust will save around $1.5 million, with the phase two trial now set to take place six to nine months earlier.
PharmAust and the Walter and Eliza Hall Institute of Medical Research in Melbourne uncovered MPL as a potentially beneficial treatment to COVID-19 back in April 2020.
Testing supported this idea, indicating both MPL and monepantel sulfone (MPLS) treatment suppressed COVID-19 cell-to-cell infectivity by roughly 95%.
Further testing together revealed MPL and MPLS reduced viral ribonucleic acid (RNA) in culture virus media as well as reduced viral secondary infections.
Addressable markets
The addressable COVID-19 market, should phase 2 COVID-19 trial results demonstrate prevention against SARS-COV2 induced cell death, would be in the US$10 billion range.
For treating ALS/MND, the addressable market is around US$3.6 billion, with Riluzole already reaching US$1 billion in annual sales.
PharmAust already in “confidential negotiations” with “a leading global pharmaceutical company” to co-develop and commercialise MPL in veterinary cancers. The pet cancer therapeutics market exceeded US$220 million in 2020 and is expected to reach $432 million by 2027.
Finally, the biggest market of them all, and the one that is very much in play with clinical outcomes in canines facilitating rapid translation to humans, is the ‘Blue Sky’ US$125 billion human cancer industry.