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.