US-based Amplyx Pharmaceuticals has obtained exclusive global rights from Novartis to a monoclonal antibody, MAU868, to prevent and treat BK viral disease.
Financial details of the agreement are yet to be disclosed.
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Primary BKV virus infection is usually asymptomatic or may cause mild flu-like symptoms. The virus then remains inactive in kidney and bladder, reactivating only when the immune system becomes weak.
In kidney transplant patients, BKV can result in the loss of the renal allograft. Furthermore, the reactivation of the virus in the bladder is associated with haemorrhagic cystitis.
BKV-related renal nephropathy and hemorrhagic cystitis currently lack approved therapies.
MAU868 targets the VP1 capsid protein necessary for the virus to infect new cells. The monoclonal antibody neutralises all four BKV genotypes.
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By GlobalDataAmplyx intends to study the anti-viral candidate in two Phase II proof-of-concept clinical trials.
Amplyx Pharmaceuticals president and CEO Ciara Kennedy said: “MAU868 builds on Amplyx’s significant experience from the fosmanogepix (APX001) programme, currently in development for the treatment of life-threatening invasive fungal infections and expands the company pipeline of novel treatments for debilitating and life-threatening diseases in patients with compromised immune systems.
“We anticipate starting Phase II trials in the near future and longer-term, seeking approval for MAU868 as the first antiviral drug for BKV disease.”
The company also reported that initial data from Phase II open-label trial of fosmanogepix showed treatment success in candidemia patients.
Data from the first ten participants revealed that fosmanogepix was able to clear Candida from their blood. The patients were alive after therapy and also did not use any other systemic anti-fungal treatments post-study.
The Phase II trial will continue towards the target enrolment of a total of 20 subjects across the US and Europe, as well as Israel.
