Otsuka Pharmaceutical has reported positive interim results from its ongoing Phase III trial evaluating sibeprenlimab, an investigational treatment for adults with immunoglobulin A nephropathy (IgA nephropathy).
Engineered by Otsuka subsidiary Visterra, sibeprenlimab is a monoclonal antibody targeting the immune pathogenic cascade of IgA nephropathy. The disease, also known as Berger’s disease, can progress to end-stage kidney disease (ESKD) over time.
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The Phase III randomised, multicentre, double-blind, placebo-controlled VISIONARY trial enrolled approximately 530 adult subjects.
It aims to assess the efficacy and safety of sibeprenlimab 400mg administered every four weeks subcutaneously, in comparison to a placebo.
An independent data monitoring committee conducted a pre-specified interim analysis, in which it concluded that sibeprenlimab led to a significant reduction in the 24-hour urine protein-to-creatine ratio (uPCR) after nine months of receiving the treatment.
The VISIONARY study has also met its primary endpoint, showing a meaningful reduction in urine protein levels.
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By GlobalDataOtsuka Pharmaceutical Development and Commercialisation executive vice-president and chief medical officer John Kraus said: “The positive interim data from this trial suggest that by targeting APRIL, we could provide a new therapeutic strategy for people living with this progressive kidney disease.
“We look forward to the completion of this study and reviewing the full results at a future time point. We are deeply appreciative to the patients with IgA nephropathy who participated in this trial, their caregivers, and investigators, all of whom continue to contribute greatly to this research.”
Sibeprenlimab received breakthrough therapy designation from the US Food and Drug Administration (FDA) in February this year, following positive outcomes from the Phase II ENVISION trial.
The ongoing Phase III study will further evaluate the impact on kidney function over 24 months and is expected to conclude in early 2026.
Otsuka is set to discuss these interim results with the FDA, potentially preparing for an accelerated regulatory submission.
This development follows Otsuka’s recent acquisition of Jnana Therapeutics in September, which was initiated in August.
