RNA-targeted medicine company Ionis Pharmaceuticals Inc (Nasdaq: IONS) and healthcare company Roche on Wednesday reported positive interim results from the Phase 3 IMAgINATION study of investigational sefaxersen in adults with primary IgA nephropathy (IgAN). The study met its primary endpoint, with sefaxersen producing statistically significant and clinically meaningful reductions in proteinuria versus placebo at 37 weeks.
The once-monthly subcutaneous treatment showed a safety and tolerability profile consistent with previous data, with no new safety signals identified. The study will continue in a blinded phase to assess kidney function at week 105.
Interim results will be presented at an upcoming medical congress and shared with health authorities. The study enrolled 459 patients at high risk of disease progression.
IgAN is a chronic, progressive autoimmune kidney disease typically diagnosed before age 40, with up to 50% of patients progressing to end-stage kidney disease within 20 years of diagnosis. Roche licensed sefaxersen from Ionis for complement-mediated diseases, with Ionis eligible for regulatory and sales milestones and tiered royalties on net sales.
Genentech reports positive Phase II results for enicepatide in type 2 diabetes
Pharming reports positive Phase II data for leniolisib in primary immunodeficiencies
Insmed's ARIKAYCE sNDA granted priority review by FDA
Precigen announces FDA platform technology designation for AdenoVerse
Enhertu recommended for EU approval in early HER2-positive breast cancer
PureTech receives FDA Fast Track designation for LYT-200 in HR-MDS
CHMP recommends EU approval of Klygefa for generalised myasthenia gravis
Coiled Therapeutics completes enrolment in two AO-252 formulation cohorts
MaaT Pharma outlines potential Phase 3 development plan for MaaT013 after CHMP negative opinion
Kemp Proteins partners with NeuImmune to advance precision protein production
Bayer's Kerendia wins FDA approval for chronic kidney disease associated with type 1 diabetes