Memo Therapeutics kicks off phase II/III trials after receiving FDA Fast Track Designation
The U.S. Food and Drug Administration has granted Fast Track designation to AntiBKV, Memo Therapeutics’ lead antibody that targets B.K. polyomavirus infection commonly seen in renal transplant patients. AntiBKV has completed a phase I clinical study and, following FDA clearance, has started actively recruiting patients for a pivotal phase II/III clinical trial. The drug is scheduled to be launched in 2025.
Memo Therapeutics AG (MTx) is a biotech company developing best-in-class therapeutic antibodies to transform the lives of patients with virus infections and cancer. MTx’s lead program, AntiBKV, is a highly effective and safe neutralizing antibody to treat B.K. polyomavirus (BKV) infection in kidney transplant recipients.
BKV infection occurs mainly in childhood and remains dormant in healthy individuals. However, BKV infection poses a significant threat following kidney transplantation, with serious adverse effects on graft function and, ultimately, patient survival. Due to the immunosuppressive drug regimen transplant patients receive, reactivation of BKV is triggered in 40 to 50% of kidney transplant recipients. Up to 10% then progress to BKV-associated nephropathy, the leading cause of graft loss. Currently, no disease-modifying therapy is available to treat BKV infection – it can only be treated by lowering immunosuppression, which significantly increases the risk of a graft rejection reaction, leading to impaired functionality and longevity or graft failure.
MTX has received the FDA Fast Track Designation for AntiBKV. The FDA Fast Track process has been designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. This means important new drugs could potentially get to the patient earlier. AntiBKV antibody therapeutic has the potential to be the first- and best-in-class treatment.
“Receiving Fast Track designation from the FDA is a significant achievement for Memo, validating the potential of AntiBKV and expediting its development. We believe AntiBKV could be a first- and best-in-class treatment option for kidney transplant patients suffering from BKV infection,” said Karsten Fischer, Chief Executive Officer of Memo Therapeutics AG.
“AntiBKV demonstrated very promising results in our phase I trial. We have recently started recruitment into a pivotal phase II/III clinical trial in the U.S. and plan for a subsequent BLA submission in 2024. We hope then to be able to offer patients a much needed therapeutic option by 2025 at the latest”, adds Karsten.
(Press release/RAN)
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