First patient enrolled in pivotal clinical phase 3 study NEFIGARD with lead candidate Nefecon
Calliditas Therapeutics AB (publ) (”Calliditas”) today announced that the first patient has been enrolled in the company’s pivotal clinical phase 3 study NEFIGARD in patients with IgA nephropathy (IgAN).The NEFIGARD trial will study the effect of Nefecon versus placebo on proteinuria in patients with IgAN. Based on positive results from the first 200 dosed patients, Calliditas plans to file for market approval with regulatory agencies. Top line data is expected in H2 2020. It follows the successful Phase 2b trial of 150 patients, NEFIGAN, which results were published in the Lancet in 2017