Vera Therapeutics shares updates on investigational therapy atacicept
Click Here to Manage Email Alerts
Vera Therapeutics Inc. announced new data for its product candidate atacicept in two presentations at the European Renal Association Congress in France.
Presentations included results from the phase 2a JANUS trial in patients with IgA nephropathy (IgAN) and a post-hoc analysis of the phase 2 APRIL-SLE study in patients with systemic lupus erythematosus (SLE).
“We are excited to share these new data from the phase 2a JANUS clinical trial which we believe make atacicept the first known investigational therapeutic to reduce IgG autoantibodies, as well as its autoantigen, Gd-IgA1. Increased levels of both have been shown to correlate with increased risk of progression. We expect the ongoing phase 2b ORIGIN trial evaluating up to atacicept 150 mg in patients with IgAN to help determine how these reductions in Gd-IgA1 and anti-Gd-IgA1 translate to measures of renal function, including proteinuria and GFR,” Celia Lin, MD, chief medical officer at Vera Therapeutics, said in the press release.
The phase 2a JANUS trial was randomized and placebo controlled. Researchers examined 16 patients with IgAN for serum anti-Gd-IgA1 at baseline and at follow-ups. Analyses revealed a decrease in serum anti-Gd-IgA1 levels in both atacicept 25-mg and 75-mg groups over time.
“It is well-known that Gd-IgA1 plays a central role in the pathogenesis of IgAN. As a result, it is exciting to report that, based on our knowledge, the phase 2a JANUS trial is the first study to show a therapeutic substantially reduced serum Gd-IgA1 in patients with IgAN. In addition, we know that IgAN patients also develop antibodies against this Gd-IgA, which is another key factor in disease pathogenesis and progression,” Jonathan Barratt, PhD, FRCP, study author and the Mayer Professor of renal medicine at the University of Leicester, said in the release. “The ability of atacicept to decrease both circulatory Gd-IgA1 and anti-Gd-IgA1 autoantibodies, both of which are central to the pathogenesis and progression of IgAN, support its potential as a disease-modifying therapy for patients with IgAN.”
David Isenberg, MD, study author, ARC Diamond Jubilee Professor and director of the Centre for Rheumatology and Bloomsbury Rheumatology Unit at the University College London, presented the results of the phase 2 APRIL-SLE study.
Researchers randomized patients with moderate to severe SLE to atacicept 75 mg (n=112), atacicept 150 mg (n=62) or placebo twice weekly for 4 weeks, then weekly for 48 weeks (n=111). Over time, the eGFR declined 4.4% among the placebo group, whereas it remained stable in the atacicept groups. Similarly, the urine protein creatine ratio increased in the placebo group and decreased in the atacicept groups.
“Results from this post-hoc analysis of the phase 2 trial of atacicept in SLE suggest atacicept may improve renal function in patients with mild to moderate SLE renal disease. These data are encouraging and supportive of further investigating atacicept to treat lupus nephritis in a planned pivotal phase 3 clinical trial, which is expected to be initiated in 2022,” Isenberg said in the release.
Lin concluded, “We anticipate the planned phase 3 COMPASS clinical trial evaluating atacicept 150 mg to help determine whether atacicept improves renal function in moderate to severe lupus nephritis. We look forward to continuing to advance our clinical program for atacicept in these serious kidney diseases so that we can help patients in need as quickly as possible.”
Click Here to Manage Email Alerts