FDA Grants Breakthrough Designation to Atacicept for IgA Nephropathy

Following the presentation of interim study results at the 61st European Renal Association Congress, Vera Therapeutics announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to its drug atacicept to treat IgA nephropathy (IgAN).

The designation, which will expedite the development and review of the drug, was based on an assessment of data from the phase 2b ORIGIN clinical trial of atacicept for IgAN, which showed the stabilization of estimated glomerular filtration rate (eGFR) over 72 weeks of treatment. Study participants received atacicept in a 36-week double-blind period, then continued to receive atacicept 150 mg self-administered subcutaneously once weekly at home during 36 additional weeks of open-label follow-up.

The eGFR stabilization aligned with an eGFR profile more consistent with that of the general population rather than patients presenting with IgAN. Vera believes eGFR stabilization with atacicept marks a substantial potential improvement over current therapies. The company stated that it plans to announce 96-week results from the phase 2b ORIGIN trial later this year and expects primary end point results from the phase 3 ORIGIN 3 trial to be revealed in the first half of 2025 to support submission for regulatory approval of atacicept in IgAN.

ORIGIN 3 will evaluate the safety and efficacy of atacicept 150 mg in patients with IgAN who continue to have persistent proteinuria and remain at high risk of disease progression despite being on a stable prescribed regimen of renin-angiotensin system inhibitors for at least 12 weeks at the maximum labeled or tolerated dose. The primary end point is the change from baseline in proteinuria as evaluated by urine protein-to-creatinine ratio at week 36.