Novel biologic investigational therapeutic: recombinant fusion protein containing the soluble TACI receptor that binds to the cytokines BAFF and APRIL, members of the tumor necrosis factor family that stimulate B cells and plasma cells to produce autoantibodies associated with IgA nephropathy (IgAN)1 and lupus nephritis (LN)2
Well-tolerated safety profile in clinical studies including >1,500 patients across multiple indications3
Self-administered once weekly by 1-mL subcutaneous injection
Vera holds an exclusive worldwide license for the development and commercialization of atacicept in all indications from Merck KGaA, Darmstadt, Germany, a leading science and technology company
BAFF = B-cell activating factor; APRIL = A proliferation-inducing ligand; TACI = transmembrane activator and CAML interactor.
1Macpherson AJ, et al. Mucosal Immunol 2008; 2Dillon SR, et al. Arthritis Res Ther 2010; 3Gordon C, et al. Rheumatol Adv Pract 2019 and data on file.
IgA Nephropathy (IgAN)
IgAN, also known as Berger’s disease, is an autoimmune disease driven by the deposition of abnormal immune complexes that accumulate in the kidneys, causing inflammatory tissue damage and kidney failure
IgAN is a serious and progressive disease with an average age at diagnosis of 30 years old, leading to severe impact on quality of life2
Up to 50% of IgAN patients progress to end-stage kidney disease within 20 years, requiring dialysis or kidney transplant3,4
Current standard of care includes ACEi/ARBs and supportive care5
There is a high unmet medical need for safe and effective new treatments for IgAN that target the source of disease6,7
ACEi = angiotensin-converting enzyme inhibitor; ARB = angiotensin II receptor blocker. 1Wyatt RJ, et al. N Engl J Med 2013; 2Jarrick S, et al. J Am Soc Nephrol 2019; 3Kwon CS, et al. J Health Econ Outcomes Res 2021; 4Pitcher D, et al. Clin J Am Soc Nephrol 2023; 5KDIGO 2021; 6Maixnerova D, et al. J Clin Med 2022; 7Huang X, Xu G. Front Pharmacol 2021.
BAFF/APRIL Dual Inhibition
Click below to learn why dual inhibition of BAFF/APRIL matters
While BAFF is known to bind all three receptors, its biologic effect is lessened when binding mature B-cell TACI and BCMA. 1Schneider P. Curr Opin Immunol 2005; 2Xin G, et al. J Nephrol 2013; 3Cao Y, et al. Mol Med Rep 2020; 4Zhai Y, et al. Medicine (Baltimore) 2016; 5McCarthy D, et al. J Clin Invest 2011; 6Haselmayer P, et al. Eur J Immunol 2017; 7Benson M, et al. J Immunol 2008; 8Yeh T, et al. J Allergy Clin Immunol 2020; 9Tsiantoulas et al. Nature 2021; 10Vallerskog T, et al. Arthritis Res Ther 2006.
Atacicept is uniquely able to substantially reduce Gd-IgA1, the core of the immune complexes that cause disease progression and mortality in IgAN patients.1
Click through the pathway below to learn about the roles of BAFF, APRIL, and atacicept in IgAN pathophysiology
Gd-IgA1 = galactose-deficient immunoglobulin A1. 1Wyatt RJ, et al. N Engl J Med 2013; 2Xin G, et al. J Nephrol 2013; 3Cao Y, et al. Mol Med Rep 2020; 4Zhai Y-L, et al. Medicine (Baltimore) 2016; 5Benson MJ, et al. J Immunol 2008; 6Haselmayer P, et al. Eur J Immunol 2017; 7Bagchi S, et al. PLoS One 2019; 8Zheng S, et al. JCI Insight 2020; 9Lafayette R, et al. ERA 2023 late breaking oral presentation, June 17; 10Suzuki H, et al. J Clin Invest 2009; 11Xie X, et al. J Pathol 2021; 12Barratt J, et al. ERA 2022; 13Zhang X, et al. Clin J AM Soc Nephrol 2021; 14Barratt J, et al. ASN 2022.
Multinational, randomized, double-blind, placebo-controlled Phase 2b clinical trial evaluating the safety and efficacy of atacicept in patients with IgAN who continue to have persistent proteinuria and remain at high risk of disease progression.
BAFF is also known as B Lymphocyte Stimulator or BLyS.
Results of the ORIGIN Double-Blind Treatment Period
Click each endpoint to learn more
Met primary endpoint: statistically significant proteinuria reduction with atacicept vs placebo at 24 weeks
Atacicept 150 mg vs placebo in per-protocol analysis at 36 weeks: Δ43%; p = 0.003
eGFR through 36 weeks
Placebo group showed expected decline
Atacicept 150mg led to stable eGFR
Difference in eGFR changes
Statistically significant: 11%; p=0.038
Clinically meaningful - 5.8 mL/min/1.73m2
Gd-IgA1 reduction from baseline with atacicept 150 mg at 36 weeks
First B cell modulator to demonstrate substantial Gd-IgA1 reduction in a multinational, doubleblind placebo-controlled trial
Atacicept was well-tolerated through 36 weeks
No increased rate of infections compared to placebo
Low rate (2%) of serious adverse events overall
No drug discontinuations or interruptions due to hypogammaglobulinemia
Multinational, randomized, double-blind, placebo-controlled Phase 3 clinical trial evaluating the safety and efficacy of atacicept 150 mg in adults with IgAN who continue to have persistent proteinuria and remain at high risk of disease progression.