Amplyx Pharmaceuticals, a biotech company dedicated to developing innovative therapies for debilitating and life-threatening diseases in patients with compromised immune systems, had positive news about its lead programme, APX001 (fosmanogepix), a treatment for the yeast infection, candidemia.
Amplyx said that two independent review committees have completed their planned safety and efficacy assessment of data from 50% of the planned study population enrolled in the Phase 2 open-label clinical trial of APX001.
The Data Review Committee adjudicated that fosmanogepix demonstrated a high level of treatment success at the end of study drug treatment.
The Data Safety Monitoring Board recommended that the study continues according to the protocol. The Phase 2 study will continue to enrol patients, with a planned total of 20 patients by the end of the year, across sites in the United States, Europe and Israel.
“These initial clinical trial results represent the first efficacy data in patients and support the highly differentiated profile of fosmanogepix for the treatment of serious fungal infections, representing an important milestone for the fosmanogepix Phase 2 candidemia study,” said Ciara Kennedy, the president and chief executive officer of Amplyx.
Amplyx also announced that it has acquired the rights to the Phase 2 anti-BK virus (BKV) monoclonal antibody, MAU868, for the treatment and prevention of BKV disease, from drugs giant, Novartis.
The company is planning two Phase 2 proof-of-concept clinical trials of MAU868 in BKV disease.
“The addition of MAU868 to the Amplyx pipeline leverages the company’s significant experience from fosmanogepix (APX001),” Kennedy said.
“We anticipate starting Phase 2 trials in the near future and, longer-term, developing MAU868 as the first antiviral drug for BKV disease,” Kennedy added.
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