Zigakibart 52-Week Data Demonstrate Potential in IgA Nephropathy

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Jonathan Barratt, MD, discusses the 52-week data from the phase 1/2 trial of zigakibart, which was presented at the 61st European Renal Association Congress.

Data from a phase 1/2 trial presented at the 61st European Renal Association Congress suggests that zigakibart was well-tolerated through 52 weeks, with results also pointing to potential efficacy benefits.

Presented by Jonathan Barratt, MD, of the University of Leicester, 52-week results of the 4-part trial suggest use of the anti-APRIL monoclonal antibody was not only well-tolerated, but also associated with durable reductions in serum levels of IgA, IgM, and IgG through 52 weeks of treatment among patients with IgA nephropathy.1

Named ADU-CL-19, the ongoing phase 1/2 trial was launched in 2019 to explore the effects of zigakibart among patients with biopsy-confirmed IgA nephropathy. Per trial protocol, parts 1 and 2 of the trial assessed single and multiple ascending doses of zigakibart in healthy adults. According to data from ERA 24, a total of 40 patients were included in cohorts 1 and 2 for the trial and completed 52 weeks of treatment.1,2

Per trial protocol, cohort 1 received 450 mg of zigakibart administered intravenously every 2 weeks for 24 weeks followed by a transition to 600 mg of zigakibart administered subcutaneously every 2 weeks while cohort 2 received 600 mg of zigakibart subcutaneously every 2 weeks. In part 3 of the study, which is ongoing, patients with IgA nephropathy received zigakibart for up to 124 weeks.1

The primary aims of the trial were to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, pharmacodynamic effects and effect on proteinuria.1

Upon analysis, investigators found zigakibart was well-tolerated among patients included in the trial. Assessments of treatment-emergent adverse events revealed such events occurred among 85% of patients, but none of these events were considered serious or led to study drug discontinuation. Investigators pointed out infections were the most common treatment-emergent adverse events, were grade 1 or 2 in severity, and experience day 77.5% of patients.1

Further analysis indicated use of zigakibart was associated with durable reductions in serum levels of IgA, IgM, and IgG of 67%, 78%, 35%, respectively, at 52 weeks among patients with IgA nephropathy. Additionally, assessments of proteinuria revealed zigakibart was associated with a 53% clinically meaningful reduction in proteinuria in the healthy adults from cohorts 1 and 2.1

For more on the trial, check out our interview with Barratt:

References:

  1. Barratt J, Laura Kooienga L, Agha I, et al. One year of zigakibart treatment shows clinically meaningful proteinuria reduction and good tolerability in a Phase 1/2 study of IgA nephropathy. Abstract presented at 61st European Renal Association Congress. Stockholm, Sweden. May 23-26, 2024.
  2. Clinicaltrials.gov. Safety and Tolerability of BION-1301 in Healthy Volunteers and Adults With IgA Nephropathy (IgAN). Clinicaltrials.gov. April 8, 2019. Accessed May 27, 2024. https://clinicaltrials.gov/study/NCT03945318.
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