Pharmaceutical company Calliditas Therapeutics AB on Tuesday provided an update of the ongoing pivotal Phase 3 NefIgArd study with its leading drug candidate Nefecon for the chronic autoimmune kidney disease IgA Nephropathy (IgAN).

The Swedish company said the US Food and Drug Administration (FDA) positive response has a significant impact on the ongoing pivotal Phase 3 NefIgArd study of its leading drug candidate Nefecon for the chronic autoimmune kidney disease IgA Nephropathy (IgAN).

In conjunction, the US FDA has accepted the change in design of the Part B of the NefIgArd study, which significantly simplifies and enhances the design of the confirmatory part of the study, added the company.

According to the company, the NefIgArd trial is studying the effect of Nefecon versus placebo on proteinuria in patients with IgAN at approximately 140 sites in 19 countries. The results from the top line readout of 200 dosed patients are expected in the second half of 2020 and plans to file for market approval with regulatory agencies.

Concurrently, the updated US FDA accepts the two-year eGFR based end point for the Part B of the company's study to reduce the overall time from six to around three and a half years; Read out for full approval two years after last patient is randomized; Study size reduced from 450 to 360 patients for Parts A and B in total; Option to initiate a roll over for NefIgArd patients into a repeat-dosing study subsequent to them completing the two-year pivotal study as well as allow for additional data to be generated related to disease modifying effect.