Memo Therapeutics (MTx) has enrolled the first patient in its Phase II/III trial of the AntiBKV antibody therapeutic to treat BK polyomavirus (BKV) infection in renal transplant patients in the US.
The placebo-controlled, randomised, Phase II part of the study will assess the therapeutic efficacy of the candidate in 60 renal transplant patients with BK viremia.
Four doses of AntiBKV 1,000mg every four weeks will be administered to participants against a placebo.
The proportion of participants without detectable BKV in the blood at day 92 is the primary endpoint of the study.
Number of subjects with at least a reduction of one log₁₀ copies/mL change from baseline BK viral load on day eight is the secondary endpoint. It also includes the reduction of treatment-emergent adverse events in patients up to day 92.
Following the last participant visit on day 92, an interim analysis is planned.
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Memo Therapeutics chief medical officer Dr Jürgen Beck said: “We believe that AntiBKV, with its 100x more potent neutralisation capacity than benchmark antibodies, has great potential to help renal transplant patients.
“Currently, these patients have no treatment options available to them to fight this dangerous infection.
“We are very grateful to the clinical teams that have already contributed so substantially and look forward to reporting interim results later in 2023.”
BKV infection occurs mostly in childhood and remains dormant in healthy people while a significant threat occurs following transplantation of the kidneys.
Memo Therapeutics CEO Dr Karsten Fischer said: “Based on current development timelines, we hope to be able to help this large and growing number of patients as soon as 2025.”