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Ionis Pharmaceuticals and Roche have revealed encouraging interim results from the Phase 3 IMAgINATION trial evaluating sefaxersen in adult patients with primary immunoglobulin A nephropathy, or IgAN.
By week 37, sefaxersen had met the trial’s primary objective, achieving statistical significance as well as clinical relevance in the reduction in proteinuria when compared to the placebo group. This was measured using the 24-hour urine protein-to-creatinine ratio or UPCR. Proteinuria is a major marker of renal dysfunction, and the reduction in this biomarker is associated with kidney function preservation.
Sefaxersen is being researched as a once-a-month subcutaneous medication that can be self-injected. Safety and tolerability data was in line with previous findings, and no new safety issues were discovered by the companies.
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The study is not over yet. IMAgINATION will continue as a blinded study, with the next focus being kidney function over two years. Researchers will assess estimated glomerular filtration rate, or eGFR, at week 105. Roche and Ionis have scheduled for their presentation at an upcoming medical conference.
The condition IgA nephropathy, also known as Berger’s disease, is an example of progressive autoimmune disorder of the kidneys. 50 percent of all patients with IgAN develop end stage kidney disease in about 20 years and may require dialysis or transplantation. The disease generally develops below the age of 40 and the annual incidence rate is more than 25 per million populations.
Roche licensed sefaxersen from Ionis for the treatment of complement-mediated diseases. Under the agreement, Ionis received upfront, license and development milestone payments, and remains eligible for regulatory and sales milestones as well as tiered royalties on net sales of sefaxersen
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