Memo Therapeutics granted FDA fast track for AntiBKV
AntiBKV targets BK polyomavirus (BKV) infection commonly seen in rental transplant patients.
Following discussions with the FDA, Memo has started actively recruiting patients for a ‘pivotal’ phase 2/3 clinical trial, after successfully completing its phase 1 clinical study.
FDA Fast Track
The FDA’s 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. As such, important new drugs could potentially get to the patient earlier.
Receiving Fast Track designation from the FDA is a significant achievement for Memo, which not only expedites the development of AntiBKV but validates its potential, said Dr. Karsten Fischer, chief executive officer of Memo Therapeutics.
“We believe AntiBKV could be a first- and best-in-class treatment option for kidney transplant patients suffering from BKV infection,” she added.
“AntiBKV demonstrated very promising results in our phase I trial. We have recently started recruitment into a pivotal phase 2/3 clinical trial in the US 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.”
BKV infection occurs mostly 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, which is the leading cause of graft loss.
There is currently no disease modifying therapy available to treat BKV infection; it can only be treated by lowering immunosuppression. However, this significantly increases the risk of a graft rejection reaction, leading to impaired functionality and longevity, or graft failure.