Treatment includes renal transplant patients requiring treatment for BK polyomavirus infection
Memo Therapeutics, a company focused on antibody discovery, has announced positive tolerability and safety data from the AntiBKV Phase 1 clinical trial. This therapy, an antibody targeting BK polyomavirus (BKV) infection in kidney transplant patients, met its primary endpoint.
In a Phase 1, partially randomized, single-blind, placebo-controlled clinical trial, 40 healthy adult volunteers received single and multiple escalating intravenous doses of AntiBKV. No related adverse events were seen up to his highest dose of 2000 mg during the study, and pharmacokinetics were found to be normal and linear.
Meanwhile, Memo plans to file an investigational drug application in the first quarter of 2023 and begin a multicenter study in the United States.
Dr. Karsten Fischer, CEO of Memo, said:
“With 50,000 kidney transplant surgeries performed in the US and Europe alone, AntiBKV addresses a large and rapidly growing market with an estimated size of well over $1 billion.”
Dr. Jürgen Beck, Memo’s chief medical officer, concludes: With 100 times more potent neutralizing ability than the benchmark antibody, he believes AntiBKV could be a game changer for currently seriously untreated patients if confirmed in clinical studies. “
BKV infection is a major threat in renal transplantation, severely affecting graft function and patient survival. Immunosuppressive regimens cause BKV reactivation in 40-50% of kidney transplant recipients.
Moreover, up to 10% of these cases progress to BKV-associated nephropathy, posing a serious threat to transplantation.