PharmAust advances monepantel for motor neurone disease towards FDA approval
Melbourne, Victoria
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February 28, 2024 10:50 AM Eastern Standard Time
PharmAust Limited (ASX:PAA) CEO Dr Michael Thurn tells Proactive's Stephen Gunnion that the company had a "pivotal" Pre-Investigational New Drug Application (Pre-IND) meeting with the US Food and Drug Administration (FDA) as it advances the development of monepantel, an approved veterinary drug, for motor neurone disease. Thurn highlighted the drug's potential in exploiting autophagy properties to treat motor neurone diseases by breaking down toxic protein build-ups, particularly TDP-43 aggregates in neurons. The company has completed a Phase 1 oncology clinical study for monepantel in humans and is preparing for a pivotal field trial in dogs for B cell lymphoma. A significant milestone is the upcoming end of Phase 1 for its motor neurone disease program, with data expected by the end of February. Thurn said the FDA's positive feedback indicates the potential for full approval after a 48-week study. Monepantel's mechanism, inducing autophagy, positions it as a promising treatment for various neurodegenerative diseases beyond motor neurone disease, including Alzheimer's and Parkinson's, suggesting its potential as a blockbuster drug.
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