Calliditas Therapeutics AB (publ) (”Calliditas”) today announced that the last visit of the 200th patient has taken place in Part A of the pivotal NeflgArd Phase 3 study.
The NefIgArd trial is studying the effect of Nefecon versus placebo in patients with IgA nephropathy (IgAN) at approximately 150 sites in 19 countries. It has a substantially similar design to the successful Phase 2b NEFIGAN trial, the results of which were published in the Lancet in 2017. The first patient in NeflgArd was randomized in November 2018, and in December 2019 Calliditas announced the full recruitment of Part A, encompassing 200 patients required to support a regulatory submission for potential market approval in the US and Europe (Part A). Topline data for the subjects included in Part A will read out in Q4 of 2020, and subject to positive data Calliditas plans to submit applications for market approval with regulatory agencies in the United States and the European Union in the first half of 2021.