The Food and Drug Administration (FDA) has granted Fast Track designation to AntiBKV, an investigational antibody therapeutic that targets BK polyomavirus (BKV) infection in kidney transplant recipients.
BKV infection can pose a significant threat to immunocompromised individuals such as renal transplant patients, resulting in impaired graft function and premature transplant loss.
The Fast Track designation for AntiBKV was supported by data from a phase 1 study (ClinicalTrials.gov Identifier: NCT05358106) evaluating the safety, tolerability and pharmacokinetics of the neutralizing antibody in healthy participants. No relevant adverse events were reported in the trial, even with the highest doses.
Memo Therapeutics is currently recruiting patients for a phase 2/3 study (ClinicalTrials.gov Identifier: NCT05769582), which will assess the safety and efficacy of AntiBKV in kidney transplant recipients. Patients will be randomly assigned to receive 4 doses of AntiBKV by intravenous infusion every 4 weeks or placebo. The primary endpoint of the trial is the proportion of patients without detectable BK virus in the blood at day 92.
“Receiving Fast Track designation from the FDA is a significant achievement for Memo, validating the potential of AntiBKV and expediting its development,” said Dr Karsten Fischer, Chief Executive Officer of Memo Therapeutics AG. “We believe AntiBKV could be a first- and best-in-class treatment option for kidney transplant patients suffering from BKV infection.”
Based on results from the pivotal trial, the Company anticipates filling a Biologics License Application with the FDA in 2024. “We hope then to be able to offer patients a much needed therapeutic option by 2025 at the latest,” added Fischer.
Memo Therapeutics AG receives FDA Fast Track designation for AntiBKV as treatment of BKV infection in renal transplant patients. News release. Memo Therapeutics. May 2, 2023. https://www.businesswire.com/news/home/20230501005374/en/Memo-Therapeutics-AG-Receives-FDA-Fast-Track-Designation-for-AntiBKV-as-Treatment-of-BKV-Infection-in-Renal-Transplant-Patients.