Vera Therapeutics has shown the effect of atacicept on kidney function in patients with immunoglobulin A nephropathy (IgAN) persists out to 96 weeks. The durability of the effects seen in the phase 2b trial led Evercore ISI analysts to say “this feels like a ‘functional cure’.”
Stanford University Medical Center’s Richard Lafayette, M.D., set the bar for 96-week success at a Vera investor event this month. Lafayette said it “will be considered super” if Vera shows galactose-deficient IgA is steady, proteinuria is stably down in a lower risk range and estimated glomerular filtration rate (eGFR) is below the guideline-recommended progression of less than 1 ml per minute per year.
Vera cleared that bar. After 96 weeks, the biotech saw a 66% reduction in galactose-deficient IgA1. The reduction after 72 weeks was 62%. Hematuria, the medical term for blood in the urine, resolved in 75% of patients after 96 weeks. Vera also saw a 52% reduction in proteinuria.
Those results, which are in line with earlier updates, are supported by a change in eGFR that again fell in the range seen in healthy individuals. When Vera posted the 72-week data, it quoted a study that found eGFR declines of approximately 1 mL/min/1.73m2 per year in the general population. The 96-week data were below that threshold, with eGFR declining by 0.6 mL/min/1.73m2 per year.
Evercore ISI analysts said in a note to investors that Vera “impressed with continued normalization of eGFR with just 0.6mL decline through 96 weeks, in line with the normal range.” That result prompted the analysts to start talking about atacicept as a functional cure.
Vera picked up atacicept, a fusion protein that inhibits B cells, from Merck KGaA. A series of updates from the phase 2b trial have suggested Vera can challenge for the IgAN market. Patients already have access to AstraZeneca’s SGLT2 inhibitor Farxiga, Calliditas Therapeutics’ reformulated steroid Tarpeyo and Travere Therapeutics’ endothelin and angiotensin II receptor antagonist Filspari.
Other companies including Novartis, Otsuka and Roche have drug candidates in phase 3, putting them just ahead of a pack of midphase programs. Vera is aiming to report phase 3 data in the second quarter of 2025. If the data live up to expectations, the biotech could file for FDA approval next year.