Globally, over 100,000 kidney transplants are performed annually, with up to half of these patients experiencing reactivation of BKV. Credit: Orawan Pattarawimonchai/Shutterstock.

Memo Therapeutics (MTx) has completed patient enrolment for its US-based Phase II clinical trial of potravitug, a monoclonal antibody aimed at combating BK viremia (BKV) in kidney transplant recipients.

Triggered by the BK polyomavirus, BKV poses a significant risk of kidney function decline, graft loss, and decreased patient survival in this group.

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The SAFE KIDNEY II study, a randomised, double-blind, placebo-controlled trial, is set to evaluate the tolerability, safety and efficacy of potravitug.

It has engaged 90 participants across 22 sites in the US, with top-line data anticipated by mid-2025.

MTx’s DROPZYLLA platform, a microfluidic single-cell processing engine, was instrumental in discovering potravitug.

DROPZYLLA’s capacity to biobank extensive human recombinant antibody libraries allows for the isolation of potent antibodies generated by the immune system’s response to viral infections and cancer, leading to the development of potentially superior therapeutics.

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Potravitug received fast track designation from the US Food and Drug Administration (FDA).

MTx CEO Erik van den Berg said: “There are currently no disease-modifying treatments available for BK viremia, so this clinical progress is a great milestone for both the field and Memo Therapeutics.

“I look forward to the results and subsequent discussions with stakeholders on the next steps towards potential approval. I would like to extend my thanks to the patients and investigators participating in the study.”

Subsequently, patient enrolment for the Phase II trial began in June 2023. This trial represents the most extensive placebo-controlled study to date focusing on the treatment of BKV in kidney transplant recipients.

Globally, more than 100,000 kidney transplants are performed annually, with up to half of these patients experiencing reactivation of BKV.

Furthermore, approximately 10% of these individuals may develop BK polyomavirus-associated nephropathy (BKVAN), significantly elevating the risks of kidney failure and mortality.