Calliditas Therapeutics AB (publ) (“Calliditas”) today announced that it has obtained written feedback from the US Food and Drug Administration (FDA) that will have a significant impact on the ongoing pivotal Phase 3 study, NefIgArd, with Calliditas’ leading drug candidate Nefecon for the chronic autoimmune kidney disease IgA Nephropathy (IgAN).
Calliditas has had an active dialogue with the FDA around the NefIgArd study during the year and has received acceptance of a design change of the Part B of the NefIgArd study, which significantly simplifies and enhances the design of the confirmatory part of the study.
The main implications of updated FDA advice
- Acceptance of a two-year eGFR based end point for the Part B of the study, resulting in a considerably shorter study, reducing 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, with significant positive impact on overall costs and recruitment time.
- Option to initiate a roll over for NefIgArd patients into a repeat-dosing study subsequent to them completing the two-year pivotal study. This would allow for placebo patients to cross over, and for additional data to be generated related to disease modifying effect.