Amplyx Pharmaceuticals, a biotech company dedicated to developing innovative therapies for debilitating and life-threatening diseases in patients with compromised immune systems, announced that it has executed an exclusive worldwide license agreement with Novartis under which Amplyx has acquired the rights to the Phase 2 anti-BK virus (BKV) monoclonal antibody, MAU868, for the treatment and prevention of BKV disease. Financial terms have not been disclosed.
MAU868 is a potent neutralizing monoclonal antibody with activity against BKV, which is present in 80 to 90 percent of the population. BKV reactivation can occur following kidney transplantation and may result in BKV nephropathy, a leading cause of renal allograft loss. BKV reactivation also occurs in patients who have received hematopoietic stem cell transplants (HSCT) and can lead to hemorrhagic cystitis, a painful and potentially life-threatening inflammatory condition of the bladder. BKV disease can have devastating and costly consequences in transplant patients. The company is planning two Phase 2 proof-of-concept clinical trials of MAU868 in BKV disease.
“MAU868 builds on Amplyx’s significant experience from the fosmanogepix (APX001) program, 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,” said Ciara Kennedy, Ph.D., president and CEO of Amplyx. “We anticipate starting Phase 2 trials in the near future and, longer term, seeking approval for MAU868 as the first antiviral drug for BKV disease.”