ROCHE KIDNEY DRUG HITS PRIMARY ENDPOINT IN PHASE 3
Roche and $IONS reported positive interim Phase 3 results for sefaxersen in IgA nephropathy, with the drug delivering a statistically significant and clinically meaningful reduction in proteinuria at Week 37.
Sefaxersen is a once-monthly, self-administered antisense therapy targeting complement factor B. The safety profile was consistent with prior studies, with no new safety signals.
The 459-patient trial will continue through Week 105 to evaluate long-term kidney function.
Roche licensed sefaxersen from Ionis, which remains eligible for regulatory and sales milestones plus tiered royalties on net sales.
The readout gives Ionis a second positive Phase 3 result in roughly 24 hours, following its FUS-ALS update.