PAA - PharmAust advances monepantel for motor neurone disease towards FDA approval
(NewsDirect)
PharmAust Limited (ASX:PAA) CEO Dr Michael Thurn tellsProactive'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 advancesthe development of monepantel, an approved veterinary drug, for motorneurone disease. Thurn highlighted the drug's potential inexploiting autophagy properties to treat motor neurone diseases bybreaking down toxic protein build-ups, particularly TDP-43 aggregatesin neurons. The company has completed a Phase 1 oncology clinicalstudy for monepantel in humans and is preparing for a pivotal fieldtrial in dogs for B cell lymphoma. A significant milestone is theupcoming end of Phase 1 for its motor neurone disease program, withdata expected by the end of February. Thurn said the FDA'spositive feedback indicates the potential for full approval after a48-week study. Monepantel's mechanism, inducing autophagy,positions it as a promising treatment for various neurodegenerativediseases beyond motor neurone disease, including Alzheimer's andParkinson's, suggesting its potential as a blockbusterdrug.
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