ASX-listed pharmaceutical innovator, PharmAust, will begin manufacturing Monepantel tablets for two important Phase 1 and Phase 2 human trials to study the drug’s impact on Motor Neuron Disease and certain cancers. It will be the first time PharmAust has used its Monepantel, or “MPL” drug in tablet form to investigate the anti-cancer activity of the drug in humans.
An earlier Phase 1 trial using MPL in liquid form showed some preliminary evidence of anti-cancer activity in humans, however, the trial was stopped early due to the unpalatable liquid formulation. Since then, PharmAust has successfully reformulated MPL into a tablet, negating the unpalatable characteristics of the liquid.
Following successful preclinical work in rats and dogs that compared the liquid and tablet formulations, PharmAust said it can now tailor tablet dosage to more meaningfully target drug blood levels known to elicit anticancer activity.
Due to begin in October 2021, the Motor Neuron Disease, or “MND” trial is co-funded with Australia’s FightMND not-for-profit organisation. Subject to regulatory approvals, the cancer trial in humans is scheduled to commence in late 2021, PharmAust said.
The company will make 10 kilograms of MPL as tablets in collaboration with India’s Syngene International, who can manufacture the drug to Good Manufacturing Practice, or “GMP” standards. GMP is a globally recognised standard for the manufacture of drugs used in clinical trials in the United States, Europe and Australia. Delivery of the GMP grade MPL is expected by June 2021.
PharmAust Chief Scientific Officer, Dr Richard Mollard said: “The commencement of this GMP synthesis program for clinical R&D purposes is a significant next step for PharmAust. Combining the in-house GMP manufacturing method with the in-house tablet formulation provides PharmAust with great operational certainty moving forward into the clinical trials in neurodegenerative diseases and cancer.”
PharmAust’s wholly-owned subsidiary, Epichem has conducted stability shelf-life tests of MPL over two years using feasibility batches manufactured to a non-GMP in-house standard developed with Syngene. These initial tests showed MPL purity and stability levels to be compatible for use in clinical trials. PharmAust is confident the GMP grade MPL tablets will achieve suitable plus-2 year shelf-life specifications for the upcoming clinical trials.
Syngene International Managing Director and Chief Executive Officer, Jonathan Hunt said: “Our GMP compliant manufacturing facility in Bengaluru is USFDA approved and has a track record of supporting advanced intermediates and NCEs for molecules in the early and late phase, and commercial supplies.”
PharmAust is primarily focused on developing cancer therapeutics for humans and canines. It specialises in repurposing existing drugs that have already proven to be safe for other uses, removing a number of the traditional hurdles along the road to market.
A version of MPL is registered by a major pharmaceutical company for use as a veterinary wormicide in many global jurisdictions, including the European Union, United Kingdom and Australia. PharmAust independently discovered that MPL is a novel, potent and safe inhibitor of the mTOR pathway – a pathway that has key influences on cancer growth and neurodegenerative diseases.
The company has been testing two independent hypotheses - that MPL could make cancer disappear and that MPL could stop cancer growing. Previously, it had demonstrated that MPL liquid inhibits cancer growth in pet dogs.
PharmAust said the fact that MPL was already approved for use in animals in a number of global jurisdictions meant the development process was simpler and cheaper than it would otherwise be if MPL were a new active pharmaceutical ingredient.
The next human trials mark a critical step for PharmAust and the development of MPL as an effective treatment for cancer and neurodegenerative diseases such as MND.
The latest human trials will be significant because they will not only determine the logistical effectiveness of taking a tablet rather than a liquid form of the drug, but they will also add to PharmAust’s growing evidence bank that MPL may have a definitive impact on some cancers.
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By Matt Birney
