Calliditas Therapeutics has announced positive topline results from Part A of the global Phase 3 clinical trial NefIgArd, which investigated the effect of Nefecon versus placebo in patients with primary IgA nephropathy (IgAN).
The trial met its primary objective of demonstrating a statistically significant reduction in urine protein creatinine ratio, UPCR or proteinuria, after 9 months of treatment with 16 mg of Nefecon compared to placebo, with significant continued improvement at 12 months. The trial also met the key secondary endpoint showing a statistically significant difference in estimated glomerular filtration rate or eGFR after 9 months of treatment with Nefecon compared to placebo, states the company. Collectively the efficacy data from 9 months treatment with 16 mg of Nefecon indicated a significant and beneficial effect on key factors correlated to the progression to end stage renal disease (ESRD) for IgAN patients. In addition, the trial showed that Nefecon was generally well-tolerated.
“A pioneer in IgAN for many years”
On the basis of these results, Calliditas plans to submit for accelerated approval with the US Food and Drug Administration (FDA) in Q1 2021 followed by a submission for conditional approval with the European Medicines Agency in H1 2021. Subject to approval by the FDA, Calliditas intends to commercialize Nefecon for IgAN by itself in the United States and through collaborations in other regions.
“We are delighted with this strong data set which confirms the results seen in the Phase 2b trial and provides further support for effectively treating IgAN at its origin. Calliditas has been a pioneer in IgAN for many years and we are excited to be the only company to have reported out a positive Phase 3 trial in this indication. This result brings hope to thousands of patients who today have no approved treatment alternatives,” says CEO Renée Aguiar-Lucander.
Photo of Renee Aguiar-Lucander