The Food and Drug Administration (FDA) has granted Fast Track designation to PRX012, an investigational anti-amyloid beta antibody therapy, for the treatment of Alzheimer disease.
In preclinical studies, PRX012 has been shown to bind to beta amyloid plaques and oligomers with high affinity; clearance of both pyroglutamate modified and unmodified amyloid beta plaque in brain tissue has also been observed.
The Company is currently investigating the safety, tolerability, immunogenicity, and pharmacokinetics of a single subcutaneous injection of PRX012 in healthy volunteers and patients with Alzheimer disease in a randomized, double-blind, placebo-controlled phase 1 study.
“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, PhD, President and CEO of Prothena. “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.”
In 2021, the FDA approved Aduhelm (aducanumab-avwa), the first monoclonal antibody directed at the underlying pathophysiology of Alzheimer disease. The treatment is administered as a monthly intravenous infusion.
The FDA’s Fast Track designation has also been granted to lecanemab (BAN2401), an investigational anti-amyloid beta protofibril antibody for early Alzheimer disease.
Prothena receives FDA Fast Track designation for PRX012, a next-generation anti-amyloid beta antibody under investigation for the treatment of Alzheimer’s disease. News release. Prothena Corporation plc. Accessed April 26, 2022. https://www.globenewswire.com/news-release/2022/04/26/2429119/24041/en/Prothena-Receives-FDA-Fast-Track-Designation-for-PRX012-a-Next-Generation-Anti-Amyloid-Beta-Antibody-Under-Investigation-for-the-Treatment-of-Alzheimer-s-Disease.html