Otsuka's investigational antibody, sibeprenlimab, demonstrated a 51.2% reduction in proteinuria compared to placebo at nine months in a large phase 3 trial for immunoglobulin A nephropathy (IgAN), which is the strongest result reported to date in this disease area125.
The phase 3 VISIONARY study data were revealed at the European Renal Association Congress, confirming sibeprenlimab's statistically significant and clinically meaningful effect on the key biomarker (urine protein-to-creatinine ratio, UPCR) for IgAN125.
The safety profile of sibeprenlimab was favorable, with lower rates of treatment-emergent adverse events and serious adverse events compared to placebo12.
Otsuka has filed a Biologics License Application (BLA) for sibeprenlimab, which has received FDA Priority Review with a target action date of November 28, 20255.
Otsuka's strong results triggered a significant sell-off in Vera Therapeutics' stock, as investors compared these new data with Vera's competing IgAN drug candidate4.
Sources:
1. https://www.biospace.com/drug-development/otsuka-sees-impressive-proteinuria-reduction-in-phase-iii-igan-trial
2. https://www.fiercebiotech.com/biotech/otsukas-kidney-disease-drug-halves-upcr-levels-phase-3-study
4. https://www.biopharmadive.com/news/otsuka-vera-igan-arvinas-nda-regenxbio-duchenne/749975/
5. https://www.biospace.com/press-releases/otsuka-sibeprenlimab-phase-3-data-show-a-statistically-significant-and-clinically-meaningful-proteinuria-reduction-for-the-treatment-of-immunoglobulin-a-nephropathy-igan