There is currently no medication disease-modifying therapy available to treat BKV infection except for the lowering of immunosuppression. Memo Therapeutics’ lead candidate AntiBVK, is a highly effective and safe neutralizing antibody to treat BK virus infection in kidney transplant recipients. The drug’s first-in-human trial has met the primary endpoint of safety and tolerability.
Memo Therapeutics AG (MTx) is a Schlieren-based clinical-stage biopharma 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 BK polyomavirus (“BKV”) virus infection in kidney transplant recipients.
BKV infection poses a significant threat in kidney transplantation, with serious adverse effects on graft function and, ultimately, patient survival. Due to the immunosuppressive drug regimen, reactivation of BKV is triggered in 40 to 50% of kidney transplant recipients. Up to 10% of these cases progress to BKV-associated nephropathy, which poses a serious threat to the transplant. There is currently no disease-modifying therapy available to treat BKV infection except for lowering immunosuppression. However, this significantly increases the risk of a graft rejection reaction, leading to impaired functionality and longevity or graft failure.
In phase I, single-blind, partially randomized, placebo-controlled clinical trial, 40 healthy adult volunteers were administered single and multiple ascending intravenous doses of AntiBKV. No relevant adverse events were seen up to the highest dose of 2000 mg, and pharmacokinetics were found to be normal and linear. Having confirmed the safety and tolerability of the drug, MTx plans to submit an Investigational New Drug Application (“IND”) during the first quarter of 2023 to initiate a multicenter study in the US.
“This initial clinical data for AntiBKV is very encouraging. We believe that AntiBKV, with its 100x more potent neutralization capacity than benchmark antibodies if confirmed in clinical studies, could present a game-changer for patients who are currently seriously underserved,” said Dr. Jürgen Beck, Chief Medical Officer of Memo Therapeutics AG.
“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 USD 1 billion,” said Dr. Karsten Fischer, Chief Executive Officer of Memo Therapeutics AG.
(RAN)
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