FDA Grants Vera Breakthrough Designation for IgAN

Rare Daily Staff

The U.S. Food and Drug Administration granted Vera Therapeutics Breakthrough Therapy designation to atacicept for the treatment of the rare kidney condition IgA nephropathy.

IgA nephropathy (IgAN), also known as Berger’s disease, is a serious and progressive autoimmune disease of the kidney, for which there remains a high unmet medical need. IgAN is driven by the production of immunogenic Gd-IgA1, which triggers autoantibodies that lead to the formation of pathogenic immune complexes, which become trapped in the kidney’s glomeruli, causing inflammation and progressive damage. In up to half of patients, IgAN can lead to end-stage kidney disease or kidney failure, which has considerable morbidity and impact on patients’ lives.

Atacicept is an experimental recombinant fusion protein that contains the soluble transmembrane activator and calcium-modulating cyclophilin ligand interactor (TACI) receptor that binds to the cytokines B-cell activating factor (BAFF) and A proliferation-inducing ligand (APRIL). These cytokines are members of the tumor necrosis factor family that promote B-cell survival and autoantibody production associated with certain autoimmune diseases, including IgAN and lupus nephritis.

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.

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 believe that atacicept has the potential to be a transformative treatment for patients,” said Marshall Fordyce, 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.”

Photo: Marshall Fordyce, founder and CEO of Vera Therapeutics