Memo Therapeutics AG (MTx) has announced the completion of enrollment in its Phase II clinical trial for potravitug, a BK polyomavirus (BKV)-neutralizing antibody. The trial, conducted across 22 sites in the U.S., is evaluating the safety, tolerability, and efficacy of potravitug in kidney transplant patients suffering from BK viremia.
Addressing BK Viremia in Kidney Transplant Recipients
BK viremia is a common complication in kidney transplant recipients, with reactivation occurring in up to 50% of patients. Of these, up to 10% may develop BK polyomavirus-associated nephropathy (BKVAN), a condition that significantly increases the risk of kidney loss and patient mortality. Currently, there are no disease-modifying treatments available for BK viremia, highlighting a significant unmet medical need.
The Phase II study is a randomized, double-blind, placebo-controlled trial. It aims to assess the potential of potravitug to address this critical gap in treatment options. Topline data from the trial is anticipated in mid-2025.
Management and Investigator Perspectives
Erik van den Berg, CEO of MTx, expressed enthusiasm about the clinical progress, stating, "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."
Dr. David Wojciechowski, an investigator in the trial, added, "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."
Fast-Track Designation and Trial Significance
Potravitug has been granted fast-track designation by the U.S. Food and Drug Administration (FDA), underscoring the urgent need for effective treatments for BK viremia. The Phase II trial is the largest placebo-controlled study conducted to date for the treatment of BK viremia in kidney transplant recipients. More than 100,000 kidney transplants are performed worldwide each year, making the development of effective treatments for post-transplant complications like BK viremia crucial.
