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Prothena Receives FDA Fast Track Designation for PRX012, a Next-Generation Anti-Amyloid Beta Antibody Under Investigation for the Treatment of Alzheimer’s Disease
PRX012 is a potential best-in-class, subcutaneous anti-amyloid beta antibody therapy currently in a Phase 1 clinical study for the treatment of Alzheimer’s
About this update from Prothena Corporation Plc
[{"type":"text","content":"PRX012 is a potential best-in-class, subcutaneous anti-amyloid beta antibody therapy currently in a Phase 1 clinical study for the treatment of Alzheimer’s disease DUBLIN, Ireland, April 26, 2022 (GLOBE NEWSWIRE) -- Prothena Corporation plc (NASDAQ: PRTA), a late-stage clinical biotechnology company with a robust pipeline of investigational therapeutics built on protein dysregulation expertise, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for PRX012, a potential best-in-class anti-amyloid beta (Aβ) antibody therapy currently being investigated in a Phase 1 clinical study for the treatment of Alzheimer’s disease. The FDA’s Fast Track designation program is designed to expedite the development and review of drugs intended to treat a serious condition, such as Alzheimer’s disease, with evidence demonstrating the potential to address an unmet medical need. “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,” said Gene Kinney, Ph.D., President and Chief Executive Officer of Prothena. “We are pleased the FDA has recognized 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.” A drug candidate that receives Fast Track designation may be eligible for more frequent interactions with the FDA to discuss the drug candidate’s development plan and, if relevant criteria are met, eligibility for Accelerated Approval and Priority Review. About PRX012 PRX012 is currently being investigated in a Phase 1 clinical study for the treatment of Alzheimer’s disease. Preclinical data have demonstrated binding of PRX012 to beta amyloid plaques and oligomers with high avidity, allowing effective Aβ plaque occupancy at relatively lower dose ranges, optimal for subcutaneous delivery. Preclinical data have also demonstrated clearance of both pyroglutamate modi...