Prothena Corporation, a late-stage clinical biotechnology company based in Dublin and San Francisco, announced on April 26 that the US Food and Drug Administration (FDA) has granted Fast Track designation for its PRX012, an antibody therapy currently being investigated in a Phase 1 clinical study for the treatment of Alzheimer’s disease. 

Prothena says PRX012 is a next-generation, high binding potency antibody, designed to enable subcutaneous dosing on a patient-friendly, convenient administration schedule, potentially providing greater accessibility for patients and caregivers.

Gene Kinney, Ph.D., President and Chief Executive Officer of Prothena, responded to the designation, saying: “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 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.”

PRX012, our potentially best-in-class investigational Alzheimer’s therapy, has been granted Fast Track designation by the FDA. Exciting progress in the development of this potential therapy for patients with #Alzheimers disease and their families.

— Prothena Corporation (@ProthenaCorp) April 26, 2022

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.

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.

The Fast Track designation came about a month after the FDA cleared the investigational new drug (IND) application for PRX012.

Kinney said at the time: “With Alzheimer’s affecting more than 50 million people worldwide, we are committed to bringing a paradigm-shifting treatment to patients as quickly as possible.

"Having submitted our IND during this first quarter, we are excited to announce the initiation of this first-in-human study.

"PRX012’s high binding potency and subcutaneous administration has the potential to serve as a foundational anti-Aβ treatment for Alzheimer’s disease."

He added: “We intend to leverage our multiple decades of experience and expertise in protein dysregulation together with clinical and regulatory learnings from first-generation anti-Aβ therapies to maximize the probability of success for our PRX012 program to deliver a best-in-class treatment to patients with Alzheimer’s and their families.”