Roche and Ionis say an experimental kidney drug cut urine protein 43.1% versus placebo at 37 weeks.

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 (IONS) and Roche reported Phase 3 trial results for sefaxersen, showing a 43.1% reduction in proteinuria in IgA nephropathy patients. The reduction was statistically significant. The study enrolled 459 patients and will continue to evaluate kidney function over two years. Ionis may receive milestone payments and royalties.

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.

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.

GSK and Ionis' Hibsago (bepirovirsen) received FDA approval for chronic hepatitis B, offering a functional cure. Analysts at H.C. Wainwright see this as a significant milestone, opening the market for competitors like Gilead, Arrowhead, and Aligos. The drug is approved for a specific patient population, leaving opportunities for other therapies. Several companies will present data at the AASLD meeting in November.