Ionis reports Phase 3 kidney drug results

• Ionis Pharmaceuticals (NASDAQ:IONS) and Roche reported positive interim Phase 3 results for sefaxersen in adults with primary IgA nephropathy.
• The study met its primary endpoint, showing statistically significant and clinically meaningful proteinuria reduction compared with placebo at Week 37.
• Ionis and Roche plan to continue the trial through Week 105 to evaluate changes in kidney function.

Ionis Pharmaceuticals (NASDAQ:IONS) and Roche reported positive interim results from the Phase 3 IMAgINATION study of sefaxersen in adults with primary IgA nephropathy.

The study met its primary endpoint, with sefaxersen showing statistically significant and clinically meaningful reductions in proteinuria compared with placebo at Week 37 based on 24-hour urine protein-to-creatinine ratio measurements.

“These findings are an important advance for the field and further demonstrate the broad potential of our RNA-targeted technology to make a meaningful difference for people living with serious diseases,” said Ionis Pharmaceuticals Chief Executive Officer Brett P. Monia, Ph.D.

The companies said sefaxersen demonstrated a safety and tolerability profile consistent with previous data, with no new safety signals identified during the interim analysis.

Sefaxersen is a once-monthly subcutaneous injection designed for self-administration in people with IgA nephropathy, a chronic autoimmune kidney disease that can lead to progressive kidney damage.

Roche licensed sefaxersen from Ionis for complement-mediated diseases, with Ionis eligible for regulatory and sales milestone payments as well as tiered royalties on future net sales.