Memo Therapeutics is pressing ahead with its kidney transplant infection drug, advancing it to Phase III trials, despite falling short of its primary endpoint in a Phase II trial.
The SAFE KIDNEY II trial (NCT05769582) of the Swiss-biotech’s highly potent human BK polyomavirus (BKPyV)-neutralising monoclonal antibody, potravitug, failed to show statistical significance in undetectable BKPyV DNAemia in blood, the study’s primary endpoint.
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Despite this, the company said there was a significantly higher viral response with resolution of biopsy-proven BKPyV nephropathy (BKPyVAN) after 20 weeks of treatment.
This histological improvement in BKPyVAN indicated resolution of the underlying disease, decreasing from 51.2% to 31.6% while no change was observed in the placebo cohort.
The trial also demonstrated that potravitug dosed at 1,000mg achieved a greater reduction in BKPyV DNAemia compared to placebo, with 61.0% of patients receiving potravitug showing a ≥1-log₁₀ reduction from baseline or achieving levels below the lower limit of quantification (LLOQ) at week 20, compared to 40.5% in the placebo group.
The trial enrolled 95 patients to evaluate potravitug’s clinical effectiveness in reducing BKPyV infection in blood and kidney tissue.
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By GlobalDataGeorgetown University School of Medicine professor and principal investigator Dr Nadiesda Costa said: “The results from this trial are exciting and represent a potential breakthrough in the treatment of BKPyV infection in kidney transplant patients, especially given that there are no specific antiviral therapies for BK viremia available.
“The data showed strong results in demonstrating pathologic improvement in BKPyVAN, which, combined with a supportive safety profile, is highly encouraging for future clinical studies.”
Despite the Phase II primary endpoint miss, Memo Therapeutics plans to advance potravitug into Phase III development and will consult with regulatory authorities later this year to discuss trial design.
Potravitug was granted fast-track designation from the US Food and Drug Administration (FDA) in May 2023.
Additional Phase II data will be presented at the World Transplant Congress in San Francisco, California, on 2-6 August 2025.
Patients who have received a kidney transplant are more susceptible to infections due to immunosuppressants, which are used to avoid rejection, meaning prompt treatment of infection is vital. Currently, treatment includes antibiotics for bacterial infections, antivirals for viral infections, and antifungals for fungal infections, along with potential adjustments to immunosuppression medication.
More than 100,000 kidney transplants are conducted worldwide every year. BKPyV can become reactivated in up to 50%. In addition, up to 70% of patients with BKPyV viremia develop BKPyV nephropathy, which significantly increases the risks of kidney loss and patient death, showing a need for therapies in this space.
Another pathway being investigated is methionine adenosyltransferase 2A (MAT2A) inhibition. Researchers at the University of Cambridge, including Professor Colin Crump, have conducted research that shows that inhibiting the activity of MAT2A, a critical human host gene for BKPyV replication, elicits a robust antiviral response.
