Vera Therapeutics presents data from Phase 2b ORIGIN study

Vera Therapeutics announced the presentation of three posters – including an additional analysis of week 36 data from the Phase 2b ORIGIN study demonstrating resolution of hematuria in the majority of patients – on the company’s product candidate atacicept in patients with immunoglobulin A nephropathy at the American Society of Nephrology Kidney Week 2023, in Philadelphia, PA. Hematuria is an important indication of IgAN activity representing active inflammation of glomeruli. At week 36 of the ORIGIN Phase 2b study of atacicept in patients with IgAN, hematuria resolved in 80% of patients receiving atacicept 150 mg compared to 5% in the placebo group. High serum levels of galactose-deficient IgA1 are associated with greater risk of end-stage renal disease or death. Patients on atacicept 150 mg achieved durable and significant Gd-IgA1 reduction over 36 weeks where regardless of baseline quartile, 82% of patients achieved reduction to the lowest risk quartile. Gd-1gA1 reduction was also correlated with improvement in hematuria at week 36. An additional poster presented at Kidney Week 2023 details further safety results from the randomized, placebo-controlled period of the Phase 2b ORIGIN trial, which are consistent with the previously observed safety profile of atacicept. This analysis assessed vaccine response and immunity with atacicept in an IgAN population. Through the randomized, placebo-controlled period, infections were balanced between atacicept and placebo in both the Phase 2a JANUS and Phase 2b ORIGIN studies. Additionally, atacicept treatment was associated with continued protective immunity to diphtheria and tetanus in the JANUS study, as measured at day 1, week 48 and week 72. In the Phase 2b ORIGIN study, the atacicept and placebo groups had similar rates of overall and COVID-19 infections, and most COVID-19 infections were mild in severity and did not cause any study discontinuations.