Therapy involves renal transplant patients requiring treatment of BK polyomavirus infection.

Memo Therapeutics – a company that focuses on antibody discovery – has announced positive tolerability and safety data from its AntiBKV phase 1 clinical trial. The treatment is an antibody targeting BK polyomavirus (BKV) infection in renal transplant patients and has met its primary endpoint.

In phase 1, a partially randomised, single-blind, placebo-controlled clinical trial, 40 healthy adult volunteers were administered single and multiple ascending intravenous doses of AntiBKV. During the study, no relevant adverse events were seen up to the highest dose of 2000mg and pharmacokinetics were found to be normal and linear.

Meanwhile, Memo plans to submit an investigational new drug application during the first quarter of 2023 to initiate a multicentre study in the US.

Dr Karsten Fischer, chief executive officer at Memo, reflected: “AntiBKV has the potential to be a best- and first-in-class antibody for the treatment of BKV infection in kidney transplant recipients.

“With 50,000 kidney transplant procedures carried out in the US and Europe alone, AntiBKV addresses a large and rapidly growing market, with an estimated size well beyond $1bn.”

Dr Jürgen Beck, chief medical officer at Memo, concluded: “This initial clinical data for AntiBKV is very encouraging. We believe that AntiBKV, with its 100x more potent neutralisation capacity than benchmark antibodies if confirmed in clinical studies, could present a game-changer for patients who are currently seriously underserved.”

BKV infection presents a significant threat in kidney transplantation, with serious adverse effects on graft function and patient survival. Due to the immunosuppressive drug regimen, reactivation of BKV is triggered in 40 to 50% of kidney transplant recipients.

Furthermore, up to 10% of these cases progress to BKV-associated nephropathy, which poses a serious threat to the transplant.