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.
Avimer Bio and CNIO publish JACS study on computational design of self‑assembling protein cages
Abogen enters Novartis licensing and option agreement to advance RNA programs
Ascletis reports positive results from ASC50 clinical study for treatment of plaque psoriasis
Ionis reports positive Phase 3 sefaxersen data in IgA nephropathy
AbbVie secures EU approval for RINVOQ in polyarticular juvenile idiopathic arthritis
GSK to acquire trispecific T cell-engager from Chimagen for multiple myeloma
FDA grants Priority Review to Genentech's Enspryng for MOGAD
Kali Therapeutics' KT501 Investigational New Drug application cleared by US FDA
Antengene's Phase I study of ATG-201 in B cell-related autoimmune diseases approved in Australia
Alfasigma to acquire Nordic Pharma, expanding specialty care portfolio
European Commission approves RINVOQ for severe alopecia areata
AbCellera and Vertex agree collaboration to develop multispecific T-cell engagers