SCHLIEREN / ZURICH, Switzerland, June 5, 2026
Memo Therapeutics AG announced additional positive analyses from its Phase II SAFE KIDNEY II study evaluating potravitug, a first-in-class monoclonal antibody for the treatment of BK polyomavirus (BKPyV) infection in kidney transplant recipients. The data were presented in an oral session at the 63rd European Renal Association Congress, highlighting significant viral clearance and consistent antiviral activity in patients with a condition that currently has no approved treatment options.
Potravitug Demonstrates Significant Viral Reduction and Clearance
The presentation included new analyses from the randomized, double-blind, placebo-controlled SAFE KIDNEY II Phase II trial, as well as comparative data generated through a propensity-score-matched external control arm derived from a large multicenter real-world cohort of kidney transplant recipients. Following matching, baseline characteristics between potravitug-treated patients and controls were highly comparable, allowing for a robust evaluation of treatment outcomes. Results showed that patients receiving potravitug experienced significantly stronger antiviral responses compared with matched controls. By Week 20, the cumulative probability of achieving at least a 1-log10 reduction in viral load reached 64.1% in the potravitug group compared with 44.8% among controls. In addition, viral clearance rates were substantially higher, with 44.9% of treated patients achieving viral clearance by Week 20 versus 27.3% in the control group, demonstrating a statistically significant improvement.
Addressing a Major Unmet Need in Kidney Transplant Patients
BK polyomavirus infection remains one of the most serious infectious complications affecting kidney transplant recipients and can lead to BK polyomavirus-associated nephropathy (BKPyVAN), a condition that threatens long-term graft survival. Despite the clinical burden of the disease, no approved therapies currently exist. Potravitug is a highly potent human monoclonal antibody specifically designed to neutralize BKPyV and reduce viral replication. According to investigators, the latest findings reinforce previous Phase II results showing consistent reductions in viral load and biopsy-proven BKPyVAN. Researchers noted that the favorable antiviral effects observed across multiple analyses strengthen confidence in the therapeutic potential of potravitug and support its continued clinical development.
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Phase III Program Planned for 2026
Memo Therapeutics stated that the positive findings further strengthen the clinical profile of potravitug as a potential first targeted therapy for BK polyomavirus infection in kidney transplant recipients. The company plans to initiate the pivotal SAFE KIDNEY 3 Phase III program later in 2026 to further evaluate the antibody’s efficacy and safety. Regulatory momentum for the program continues to build, with potravitug having previously received Fast Track designation from the U.S. Food and Drug Administration (FDA) and Orphan Drug Designation in the European Union. The company believes these latest Phase II results provide strong support for advancing potravitug toward registration studies and ultimately bringing a much-needed treatment option to transplant patients affected by BKPyV infection.
Source: Memo Therapeutics press release
