Calliditas Therapeutics, a leading Swedish specialty pharmaceutical firm, has reportedly unveiled positive topline outcomes from Part A of Phase 3 clinical study, NefIgArd, that assessed the efficacies of Nefecon® against placebo for patients suffering from IgAN (IgA nephropathy).
The clinical study has met its primary aim of showing a statistically significant drop in proteinuria or UPCR (urine protein creatinine ratio), after treating nephropathy patients with 16 mg of Nefecon for 9 months compared to placebo, with substantial improvements over 12 months.
The trial analyzed 199 patients suffering from primary IgA Nephropathy that were on the background of stable and optimized RAS (renin-angiotensin system) inhibitor therapy.
The clinical study also met the crucial secondary endpoint, demonstrating a statistically substantial difference in the eGFR or estimated glomerular filtration rate after treatment of a patient with Nefecon for 9 months in comparison to placebo.
Together, the efficacy data of the IgAN patients treated for 9 months with 16 mg of Nefecon showed a beneficial and significant effect on crucial factors that were correlated to progression to ESRD (end stage renal disease). Additionally, the study also demonstrated that Nefecon was well-tolerated among patients.
Based on these outcomes, the company aims to apply for accelerated approval to the US FDA (Food and Drug Administration) in the first quarter of 2021 after the submission of a conditional approval in H1 2021 with the EMA (European Medicines Agency). Based on the FDA approval, the company plans to commercialize Nefecon for patients with IgAN in the U.S. by itself and through partnerships for other regions.
CEO of Calliditas, Renée Aguiar-Lucander, stated that the firm is thrilled with the strong outcomes, which verifies the trial results observed in the Phase 2b study and gives further support to effectively treat IgAN at its origin.
Aguiar-Lucander further added that the outcome brings hopes to a lot of people who currently have no ized therapy options.
Source Credit: https://www.prnewswire.com/news-releases/calliditas-announces-positive-topline-results-from-pivotal-phase-3-nefigard-trial-301168379.html#:~:text=Calliditas%20Announces%20Positive%20Topline%20Results%20from%20Pivotal%20Phase%203%20NefIgArd%20Trial,-News%20provided%20by&text=Collectively%20the%20efficacy%20data%20from,(ESRD)%20for%20IgAN%20patients