Roche and licensing partner Ionis Pharmaceuticals said interim results from the ongoing Phase 3 IMAgINATION study of investigational sefaxersen in adults with primary IgA nephropathy met the trial’s primary endpoint. Sefaxersen significantly reduced proteinuria versus placebo at 37 weeks, measured by the 24-hour urine protein-to-creatinine ratio, and the companies said the results were statistically significant and clinically meaningful. The once-monthly, self-administered subcutaneous antisense oligonucleotide inhibits liver production of complement factor B, an inflammatory pathway target also addressed by Novartis’ Fabhalta. Roche plans to present the data at a medical meeting and share them with regulators while continuing to assess kidney-function outcomes. If cleared, sefaxersen would enter an increasingly competitive market that includes recently authorized drugs from Otsuka Pharmaceutical and Vera Therapeutics, as well as a potential Vertex Pharmaceuticals entrant. Ionis is eligible for up to $400 million in sefaxersen-related milestone payments and sales royalties.