Long-term Results From The Origin Phase 2B Study Of Atacicept For The Treatment Of IGA Nephropathy (IGAN)

Promising Long-Term Results for Atacicept in Treating IgA Nephropathy

▪         New findings from the ORIGIN Phase 2b study open-label extension (OLE) highlight the potential of atacicept as a long-term therapy for IgA nephropathy (IgAN).

▪         The 96-week results demonstrate sustained improvements in key disease markers and stabilization of kidney function, positioning atacicept as a promising disease-modifying treatment for this chronic kidney condition.

Targeting Key Drivers of IgAN

▪         Atacicept, a TACI-Fc fusion protein, works by inhibiting two critical players in IgAN pathogenesis: B-cell activating factor (BAFF) and A proliferation-inducing ligand (APRIL). These factors contribute to the development of galactose-deficient IgA1 (Gd-IgA1), a hallmark of IgAN.

▪         Administered via subcutaneous injection, atacicept aims to provide long-term control of disease progression while maintaining kidney function.

Sustained Efficacy Through 96 Weeks

The OLE study enrolled 113 patients who had completed the initial 36-week Phase 2b trial. Participants received atacicept 150 mg for an additional 60 weeks, resulting in:

● Gd-IgA1 Reduction: A 65.9% (±1.7%) mean decrease in Gd-IgA1 levels.

● Hematuria Improvement: A 75% reduction (95% CI -87.3, -58.8) among participants with baseline hematuria.

●  Proteinuria Reduction: UPCR decreased by 52.2% (±4.7%).

●  Kidney Function Stability: eGFR remained near baseline with a mean annualized decline of -0.6 ±0.5 mL/min/1.73m²/year, mirroring rates in the general population without kidney disease.

A Safe and Durable Treatment Option

▪ Safety data showed atacicept was well-tolerated, with no unexpected adverse events.

▪This favorable profile supports its potential as a long-term therapy for IgAN patients, addressing an unmet need for treatments that offer both efficacy and safety.

Transforming the Outlook for IgAN Patients

▪         The study findings suggest that atacicept could change the trajectory of IgAN by slowing disease progression and reducing the risk of kidney failure.

▪         By stabilizing kidney function and lowering key disease markers, atacicept provides a potential pathway to improved long-term outcomes for patients.

▪         Further studies will help solidify atacicept’s role in managing IgAN, but these results mark an encouraging step forward in the development of effective treatments for this challenging condition.

By - Dr. Anupam Aggarwal

Reference: American Society of Nephrology. Presented at Kidney Week 2024.