#Applause igan drivers#
#Applause igan driver#
#Applause igan trial#

New therapeutic approaches target immunological aspects of IgAN, including complement-mediated inflammation and pathogenic antibody production by inhibiting activation or promoting depletion of B cells and CD38-positive plasma cells. With the risk of progression and limited treatment options, there is an unmet need for therapies that address the formation of pathogenic Gd-IgA1 antibody and anti-Gd-IgA1 antibody-containing immune complexes.

Disease progression is driven by the formation and deposition of immune complexes composed of galactose-deficient IgA1 (Gd-IgA1) and Gd-IgA1 autoantibodies (anti-Gd-IgA1 antibodies) in the glomeruli, where they trigger complement-mediated inflammation that can result in loss of kidney function and end-stage kidney disease (ESKD). Much-needed, targeted treatment for people living with IgAN.Immunoglobulin A nephropathy (IgAN) is a rare autoimmune disorder and the leading cause of biopsy-reported glomerulonephritis (GN) worldwide.

#Applause igan drivers#

“These data highlight the ability of iptacopan to address one of the key drivers for this disease and its potential to provide a Leicester and nephrology consultant, Leicester General Hospital. These efficacy data, seen after 90 days of treatment, along with the safety profile, offer hope that inhibition of theĪlternative complement pathway with iptacopan may be an effective way to delay IgAN disease progression,” said study lead author Jonathan Barratt, Professor of Renal Medicine, University of “IgAN is a devastating disease with no currently approved treatments. At the highestĭose of 200mg twice daily a 23% reduction in proteinuria was predicted, compared with placebo, at 90 days 1. (p=0.038) dose response effect on reduction in proteinuria (as measured by 24-hour urinary protein to creatine ratio ) with iptacopan vs. The primary endpoint was met with a statistically significant In the Phase II study (NCT03373461), patients (n=112) with IgAN were randomized to placebo or different doses of iptacopan 1. The data were presented at theĥ8 th ERA-EDTA Congress held virtually from June 5–8, 2021. Showing investigational iptacopan (LNP023) – a first-in-class, oral, targeted factor B inhibitor – reduced protein in the urine (proteinuria), an increasingly recognized surrogate markerĬorrelating with progression to kidney failure 2, and showed promise in stabilizing kidney function in patients with IgA nephropathy (IgAN) 1.

#Applause igan driver#

Iptacopan is in development for several complement-driven renal diseases (CDRDs), including IgAN and C3 glomerulopathy ( C3G ), and the bloodĭisorder paroxysmal nocturnal hemoglobinuria (PNH), targeting a key driver of these diseasesīasel, June 0 6, 20 2 1 - Novartis today announced Phase II primary endpoint data.There are no currently approved treatments for IgAN – a r are and often progressive kidney disease that mainly affect s young adults and can progress to kidney failure 3-7.

#Applause igan trial#

Iptacopan also showed a trend toward stabili zation of kidney function 1 Phase III clinical trial APPLAUSE is.Meaningful reduc tion of proteinuria 1 – a key risk predictor in kidney disease progression 2 Phase II primary endpoint results for investigational iptacopan in IgAN demonstrated effective and clinically.