Antiviral effect of MAU868 against BK virus prompts further research

MAU868 – a first-in-class human immunoglobulin G1 monoclonal antibody, which has the potential to neutralise infection by blocking BK virus (BKV) – provided clinically relevant BK antiviral activity in kidney transplant patients with BK virus [1].

Immunocompromised patients are prone to (re)activation of the BKV (a polyoma virus), which can cause renal disease. Moreover, BK-associated nephropathy is a major cause of transplant loss after renal transplantation. Currently, no approved treatments for BKV are available. Dr Stanley Jordan (Cedars-Sinai Medical Center/Comprehensive Transplant Center, CA, USA) discussed the outcomes of a phase 2b, double-blind study assessing MAU868 in kidney recipients (within past year). These patients had BKV with ≥104 viral copies/mL within 10 days of randomisation or ≥103 viral copies/mL in 2 contiguous samples within 1–3 weeks. A total of 28 patients were randomised 2:1 to IV MAU868 Q28D (n=20) or placebo (n=8). Treatment duration was 12 weeks and follow-up was 24 weeks. The primary endpoint of the trial was safety, and the secondary outcome measure was viral load in response to treatment. “The baseline characteristics of the population were similar. All 28 patients completed and tolerated 12 weeks of treatment,” Dr Jordan said. “We observed a greater antiviral effect amongst patients who received MAU868 compared to those who received placebo, both at 16 and 36 weeks.” There were 2 deaths in the MAU868 group both of which were COVID-19-related. No difference in adverse events or serious adverse events was observed between the groups. It was concluded that these findings support further development of MAU868 as a therapy for BKV infection.

1. Jordan S, et al. A Randomized Phase 2 Study of MAU868 vs. Placebo to Treat BK Viremia in Kidney Transplant Recipients. SA-OR43, ASN Kidney Week 2022, 3–6 Nov.

 

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Posted on 8 December 2022