Roche’s sefaxersen shows 43% proteinuria reduction in IgAN trial

Roche (RHHBY) presented Phase 3 data for sefaxersen, showing a 43.1% reduction in proteinuria in IgA nephropathy patients. Ionis (IONS), Roche's partner, highlighted the potential of sefaxersen as a new treatment option. The study is ongoing to evaluate kidney function over two years. Roche licensed sefaxersen from Ionis, with Ionis eligible for milestone payments and royalties.

Ionis reported that Roche's Phase 3 study of sefaxersen showed a 43.1% reduction in proteinuria versus placebo in adults with IgA nephropathy, a statistically significant result. The drug was well tolerated, and Ionis may receive regulatory and sales milestones, as well as royalties, under its agreement with Roche.

IONIS PHARMACEUTICALS INC (IONS) filed an SEC Form 8-K — Other Events. Exhibit 99.1 Ionis partner Roche announces new Phase 3 data showing sefaxersen significantly reduced proteinuria in people with IgA nephropathy (IgAN) – Sefaxersen achieved a statistically significant 43.1% reduction in proteinuria, a key indicator of kidney damage, relative to p

Ionis Pharmaceuticals reported that Roche's Phase 3 IMAgINATION study showed sefaxersen reduced proteinuria by 43.1% compared to placebo at 37 weeks (P<0.0001) in adults with IgA nephropathy. The study's safety profile matched prior data, and it continues to Week 105 to assess eGFR change.

Roche and Ionis reported that sefaxersen, an experimental kidney drug, reduced urine protein by 43.1% versus placebo at 37 weeks in a Phase 3 study. The drug, designed for self-administration, aims to treat IgA nephropathy (IgAN). Ionis CEO Brett Monia stated the results support its potential to reduce long-term dialysis or kidney transplantation needs. Roche licensed sefaxersen from Ionis and will share data with health authorities.

The FDA approved Hibsago, a new hepatitis B treatment developed by GSK and Ionis. In trials, 19% of patients maintained virus control for 24 weeks post-treatment. It's for adults without cirrhosis, with specific viral load and antigen levels. The FDA warned of potential severe side effects, including hepatic reactions and low platelet counts.