Memo Therapeutics AG Announces Last Patient Enrolled in Phase II Clinical Trial of Potravitug for Treatment of BK Viremia in Kidney Transplant Patients

Schlieren / Zurich, Switzerland, 1 November, 2024 – Memo Therapeutics AG (or “MTx”), a late-stage biotech company translating unique immune responses into superior medicines to treat viral infections and cancer, announces today that the last patient has been enrolled in its 22-site U.S. Phase II trial for its BK polyomavirus (“BKV”)-neutralizing antibody, potravitug.

With topline data expected in mid-2025, the randomized, double-blind, placebo-controlled study assesses the safety, tolerability and efficacy of potravitug in kidney transplant patients. More than 100,000 kidney transplants are conducted worldwide every year. BKV can become reactivated in up to 50% of these patients and up to 10% can develop BK polyomavirus associated nephropathy (“BKVAN”), which significantly increases the risks of kidney loss and patient death.

Erik van den Berg, CEO of MTx, commented: “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 AG. 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.”

Dr. David Wojciechowski, Investigator, said: “I am pleased with the progress of the Phase II clinical trial for potravitug, which has first and best-in-class potential to treat BK viremia in kidney transplantation patients, a severe infection which increases the risk for early graft loss. I look forward to evaluating the data in close collaboration with the Safe Kidney II clinical trial investigators. Importantly, I would also like to thank all the study participants and clinical staff for their ongoing support in conducting this trial.”

MTx received fast-track designation for potravitug from the U.S. Food and Drug Administration in recognition of the high unmet medical need and lack of treatment alternatives and began enrolling patients for its Phase II clinical trial in June 2023. This is currently the largest placebo-controlled trial for the treatment of BK viremia in kidney transplant recipients ever conducted.