Memo Therapeutics Advances Potravitug to Phase III for BK Virus in Kidney Transplant Patients

Despite not meeting its primary endpoint in the Phase II SAFE KIDNEY II trial, Memo Therapeutics plans to move potravitug, its BK polyomavirus (BKPyV)-neutralising antibody, into Phase III trials by late 2025. The trial, involving 95 kidney transplant recipients, did not show statistical significance in eliminating BKPyV DNAemia, but demonstrated notable histological improvements. Biopsy-proven BKPyV nephropathy (BKPyVAN) cases dropped from 51.2% to 31.6% with potravitug, while placebo patients showed no improvement. At a 1,000mg dose, 61% of treated patients had a ≥1-log₁₀ reduction in viral load or fell below detection limits, versus 40.5% in the placebo group. Given the lack of targeted antivirals for BKPyV and its serious consequences — including graft loss and mortality — potravitug may fill a critical gap. The FDA granted fast-track designation in 2023. Additional Phase II data will be shared at the World Transplant Congress in August 2025. Regulatory consultations on Phase III design are scheduled for later this year.

25-07-2025