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FDA grants Prothena fast-track designation for next-generation Alzheimer’s disease therapy

Approximately 50 million people worldwide are estimated to be living with Alzheimer’s disease or other dementias


Prothena Corporation – a company with a broad portfolio of investigational therapeutics built on protein dysregulation expertise – has announced that the US Food and Drug Administration (FDA) has granted fast-track designation for its anti-amyloid beta antibody therapy, PRX012.

The potential ‘best-in-class’ treatment is currently being investigated in a phase 1 clinical study for the treatment of Alzheimer’s disease – a condition that, with greater global age expectation, is exponentially increasing throughout the world.

The fast-track programme is designed to accelerate the development and review of drugs intended to treat serious conditions, by incorporating compelling evidence which demonstrates the potential to address unmet medical needs.

Preclinical data has revealed that binding PRX012 to beta amyloid plaques and oligomers with high avidity allows effective Aβ plaque occupancy at relatively lower dose ranges – optimal for subcutaneous delivery.

There was also a demonstrable clearance of both pyroglutamate modified and unmodified Aβ plaque in brain tissue, using quantities of PRX012 estimated to be clinically achievable in the central nervous system with subcutaneous delivery.

Gene Kinney, president and CEO at Prothena, said: “We welcome the FDA’s decision to grant PRX012 fast-track designation, which is designed to bring important new drugs to patients sooner, and we look forward to collaborating with the FDA to expedite the development of this investigational next-generation amyloid beta-targeting therapy for the millions of patients with Alzheimer’s disease and their families.”

“We are pleased the FDA has recognised the evidence demonstrating the potential for PRX012 to address an unmet need in the treatment of Alzheimer’s disease. With its substantially higher binding strength that allows for simple subcutaneous administration, PRX012 is positioned to potentially lead a paradigm shift in Alzheimer’s treatment,” he added.

Fast-track status also comes with added advantages. A drug candidate may be eligible for more frequent interactions with the FDA to discuss development plans and, if relevant criteria are met, eligibility for accelerated approval and priority review.

Approximately 50 million people worldwide are estimated to be living with Alzheimer’s disease or other dementias, with Alzheimer’s disease being the most common neurodegenerative disorder.

Article by
John Pinching

28th April 2022

From: Regulatory



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