Calliditas Starts Dosing In Nefecon Open Label Extension Study In Kidney Disease

Calliditas Therapeutics AB (NASDAQ: CALT) has dosed that first patient in the global open-label extension part of Phase 3 study (dubbed as NefIgArd) that will offer a 9-month treatment with Nefecon to all qualifying patients who have completed the NefIgArd study and will evaluate the efficacy and safety of Nefecon treatment in patients with IgA Nephropathy (also known as Berger's disease) is characterized by the build-up of IgA, a protein made by the immune system to protect the body, in the kidneys, causing inflammation that damages kidney tissues.
The study will evaluate patients who have completed the Phase 3 study, which achieved both its primary and key secondary endpoints in the Part A topline data readout announced in November last year.
At the end of the treatment period, change in urine protein to creatinine ratio (UPCR) and estimated glomerular filtration rate (eGFR) will be evaluated. Further, a comparison between treatment naïve and patients who received Nefecon in Phase 3 NefIgArd study will be made.
As announced earlier, Calliditas plans to submit for accelerated approval with the FDA in the first quarter of 2021, followed by submission for conditional approval with the European Medicines Agency in the first half of 2021.
Price Action: CALT shares are trading higher by 2.8% at $29.7 in the premarket trading on the last check Thursday.