Ionis: Sefaxersen Cuts Proteinuria 43.1% in Phase 3 IgAN Study

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.

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.

H.C. Wainwright maintained a $100 price target for Ionis Pharmaceuticals (IONS) after GSK's Hibsago received FDA approval, which will generate royalties for Ionis. The stock is near its 52-week low, down 44% year-to-date. Analysts estimate Japan alone could generate $21M-$26M in annual royalties at peak. Other analysts have also recently upgraded or maintained positive ratings on IONS.