Ionis Shares Fall 2.23% on Day Roche Publishes Kidney Trial Results

Roche detailed results Friday, Oct. 23, from a Phase 3 trial of sefaxersen, an investigational drug licensed from Ionis Pharmaceuticals (IONS), showing a 43.1% reduction in proteinuria versus placebo at week 37, while kidney-function results remain pending.

The result involved adults with primary IgA nephropathy receiving optimized standard care. The study measured proteinuria using the 24-hour urine protein-to-creatinine ratio. The 95% confidence interval was 32.5% to 52.0%, with P<0.0001. A greater proportion of participants who had blood in their urine at the start of the study saw it resolve by week 37 on sefaxersen than on placebo.

IONS shares closed at $42.93 at 4 p.m. EDT (20:00 UTC) Friday, down $0.98, or 2.23%, from the previous close.

Roche announced Sept. 23 that the study had met its primary endpoint. The Oct. 23 results added the size of the week-37 proteinuria reduction. IMAgINATION enrolled 459 participants and randomized them 1:1 to sefaxersen or placebo for 105 weeks. The trial remains blinded, with kidney-function change to be assessed using estimated glomerular filtration rate at week 105.

No new safety signals were identified, and the safety profile was consistent with the earlier Phase 2 study. IgA nephropathy is a chronic, progressive autoimmune kidney disease typically diagnosed before age 40. It can lead to end-stage kidney disease in up to 50% of patients within 20 years of diagnosis.

Sefaxersen is designed to reduce production of complement factor B in the liver and is intended as a monthly injection under the skin. Under its agreement with Roche, Ionis has received upfront, license and development milestone payments. It is also eligible for regulatory and sales milestones and tiered royalties on future net sales. Roche plans to share the study data with health authorities.