Memo Therapeutics Advances Kidney Infection Drug to Phase III Despite Missed Endpoint

Memo Therapeutics is progressing potravitug, its monoclonal antibody therapy targeting BK polyomavirus (BKPyV) in kidney transplant recipients, into Phase III trials, despite not meeting the primary endpoint in the Phase II SAFE KIDNEY II trial. While the trial didn’t achieve statistical significance for undetectable BKPyV DNAemia, patients treated with potravitug showed notable histological improvement, with biopsy-proven BKPyV nephropathy (BKPyVAN) cases dropping from 51.2% to 31.6%.

Additionally, 61% of patients on potravitug achieved at least a 1-log₁₀ viral reduction or levels below quantifiable limits by week 20, versus 40.5% on placebo. These results, paired with a favorable safety profile, support further development.

The FDA granted fast track designation in 2023. Potravitug’s updated data will be presented at the World Transplant Congress in August 2025. As no approved antivirals exist for BKPyV, and reactivation affects up to 50% of kidney transplant patients, the need for targeted therapies is urgent.

31-07-2025