FDA grants Memo Therapeutics fast track designation to treat transplant-related infection
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Key takeaways:
- FDA granted fast track designation for AntiBKV.
- AntiBKV is designed to treat BK polyomavirus infections in kidney transplant recipients.
Memo Therapeutics AG received fast track designation from the FDA for AntiBKV, a drug to treat BK polyomavirus infections, according to the press release.
Currently, there are no therapeutics available to treat BK polyomavirus (BKV), an infection that commonly affects kidney transplant recipients. The infection, which typically occurs in childhood and remains dormant in healthy adults, can be triggered by immunosuppressive drugs. According to the release, 40% to 50% of kidney transplant recipients experience this infection and up to 10% experience BKV-associated nephropathy.
Ultimately, this can lead to graft loss in transplant recipients.
“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,” Karsten Fischer, PhD, CEO of Memo Therapeutics, said in the release.
“AntiBKV demonstrated promising results in our phase 1 trial. We have recently started recruitment into a pivotal phase 2/3 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.”
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