FDA Breakthrough Therapy Designation for Atacicept in Immunoglobulin A Nephropathy (IgAN)
Vera Therapeutics, Inc. (Nasdaq: VERA), a late clinical-stage biotechnology company focused on developing and commercializing transformative treatments for patients with serious immunological diseases, announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to atacicept for the treatment of IgAN.
The designation reflects the FDA’s determination that, based on an assessment of data from the Phase 2b ORIGIN clinical trial of atacicept for IgAN, atacicept may demonstrate substantial improvement on a clinically significant endpoint over available therapies for patients with IgAN.
“We are pleased that the FDA has determined that the accumulated clinical data of atacicept in IgAN may demonstrate substantial improvement on kidney function as measured by eGFR over available therapies, and we believe that atacicept has the potential to be a transformative treatment for patients,” said Marshall Fordyce, M.D., Founder and CEO of Vera Therapeutics. “Later this year we plan to announce long-term 96-week results from the Phase 2b ORIGIN trial, and in the first half of 2025 we expect the primary endpoint results from our pivotal Phase 3 ORIGIN 3 trial, which are anticipated to support submission for regulatory approval of atacicept in IgAN.”
The FDA’s Breakthrough Therapy Designation is designed to expedite the development and review of drugs that are intended to treat a serious condition and for which preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapies on one or more clinically significant endpoints.
As part of the Breakthrough Therapy Designation request, the FDA reviewed data from the Phase 2b ORIGIN trial of atacicept in IgAN which demonstrate the stabilization of eGFR over 72 weeks of treatment. Participants first received atacicept in a 36-week double-blind period, and then continued to receive atacicept 150 mg self-administered subcutaneously once weekly at home during 36 additional weeks of open-label follow-up. Importantly, the stabilization of eGFR with atacicept reflects an eGFR profile more consistent with that of the general population versus those presenting with IgAN. Vera believes the stability of eGFR with atacicept represents a substantial potential improvement over currently available therapies.
June 3, 2024
