All articles tagged with #iga nephropathy
Vera Therapeutics reported final two-year data from the ORIGIN 3 Phase 3 trial, showing that its drug Trutakna stabilized kidney function and reduced the risk of kidney-related death in patients with IgA nephropathy. Following a July accelerated approval, the company plans to seek full FDA approval in the fourth quarter of 2026.
Boulevard Bio surfaced from stealth with $65 million in funding from Deerfield Management to advance three autoimmune drug candidates. Led by Mahesh Karande and co-founded with Georg Schett, the company’s lead asset BLVD101 is a bispecific BAFF/APRIL antibody for IgA nephropathy (IgAN) with a 12-week dosing schedule and favorable interim Phase 1 safety data. The portfolio also includes BLVD201, a trispecific CD19/BCMA/CD3 T-cell engager licensed from METiS Techbio, and BLVD301 in IND-enabling stages, underpinned by 3DC’s B-cell–focused platform and Metis’ NanoForge technology. Boulevard emphasizes multi-target, patient-centric approaches to address B-cell–driven autoimmune diseases.
The FDA approved Vera Therapeutics' drug Trutakna to treat IgA nephropathy, a chronic autoimmune kidney disease that can progress to kidney failure, marking a milestone for Vera and advancing biotech options for patients.
Final 2.5-year ALIGN results show atrasentan may slow eGFR decline in IgA nephropathy vs placebo (−7.5 vs −9.9 ml/min/1.73 m2; difference 2.4 ml/min/1.73 m2; P=0.057), with notable benefit in the SGLT2 subgroup; early data showed no acute eGFR loss after starting atrasentan. Overall, atrasentan appears to offer non-immunosuppressive renoprotection, though long-term safety remains to be fully established.
Vertex reported Phase 3 data showing its IgA nephropathy drug reduced a key kidney-disease biomarker by about 50%, in a three-way race with Otsuka and Vera Therapeutics and signaling potential multi-billion-dollar annual sales.
Vertex’s povetacicept demonstrated robust Week 36 interim efficacy in the Phase 3 RAINIER trial for IgA nephropathy, including a 52.0% reduction in 24-hour UPCR (49.8% versus placebo, P<0.0001), a 77.4% reduction in serum Gd-IgA1 (79.3% versus placebo; P<0.0001), and 85.1% hematuria resolution versus 23.4% with placebo (61.7-point difference; P<0.0001). The drug was generally safe and well tolerated. Vertex plans full BLA submission by end of March for potential accelerated FDA approval, with final efficacy analysis scheduled at two years through Week 104.
Otsuka's experimental drug sibeprenlimab showed promising results in reducing toxic protein levels in patients with IgA nephropathy, outperforming Vera Therapeutics in a Phase 3 study, with fewer serious side effects.
Vera Therapeutics announced positive Phase 3 trial results for its kidney disease drug atacicept, which significantly reduced proteinuria in patients with IgA nephropathy, supporting a potential FDA submission later this year.
23-year-old Harris Cannady is in need of a kidney transplant due to a rare auto-immune disorder. His family is seeking a living donor and encouraging others to get tested to see if they are a match. The process has been challenging, but they remain hopeful and are leaning on their faith. The story also highlights the importance of organ donation and the impact it can have on saving lives.
Novartis has announced positive results from the interim analysis of its Phase III ALIGN study, which is evaluating the efficacy of atrasentan, an oral endothelin A receptor antagonist, in patients with IgA nephropathy (IgAN). The study met its primary endpoint, demonstrating superiority of atrasentan over placebo in reducing proteinuria (protein in urine) in patients with IgAN. The safety profile of atrasentan was consistent with previous data. Novartis plans to submit an application for accelerated approval based on these results, with the final readout of the study expected in the first quarter of 2026. IgAN is a progressive kidney disease that affects mostly young adults and is a major cause of chronic kidney disease and kidney failure worldwide. Novartis is developing three therapies for IgAN to address unmet needs in the treatment of the disease.