Memo Therapeutics AG (MTx) has announced the completion of patient enrollment in its Phase II clinical trial for potravitug, a BK polyomavirus (BKV)-neutralizing antibody. This marks a significant step forward in the development of a potential treatment for BK viremia in kidney transplant recipients.
The Phase II trial, conducted across 22 sites in the U.S., is a randomized, double-blind, placebo-controlled study designed to evaluate the safety, tolerability, and efficacy of potravitug. Topline data from the trial is anticipated in mid-2025.
The Need for New Treatments
Kidney transplantation is a life-saving procedure for individuals with end-stage renal disease. However, post-transplant complications, such as BK viremia, can significantly impact graft survival and patient outcomes. It is estimated that over 100,000 kidney transplants are performed worldwide annually. BKV can reactivate in up to 50% of kidney transplant recipients, and up to 10% may develop BK polyomavirus-associated nephropathy (BKVAN), a condition that elevates the risk of kidney loss and mortality.
Currently, there are no approved disease-modifying treatments available for BK viremia, highlighting a critical unmet medical need. The current standard of care primarily involves reducing immunosuppression, which can increase the risk of rejection.
Potravitug: A Potential First-in-Class Therapy
Potravitug, MTx's lead candidate, is a BKV-neutralizing antibody with the potential to be the first disease-modifying therapy for BK viremia. The U.S. Food and Drug Administration (FDA) has granted fast-track designation to potravitug, recognizing the urgent need for effective treatments for this condition.
Erik van den Berg, CEO of MTx, stated, "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." He also expressed his anticipation for the results and subsequent discussions with stakeholders regarding the next steps toward potential approval.
Trial Design and Objectives
The Phase II trial is the largest placebo-controlled study ever conducted for the treatment of BK viremia in kidney transplant recipients. The primary objective is to assess the safety and tolerability of potravitug. Secondary endpoints include evaluating the efficacy of the antibody in reducing BK viral load and preventing the progression to BKVAN.
Dr. David Wojciechowski, an investigator in the trial, commented, "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."
