XBiotech has completed the “second dose cohort” of its Phase I/II study of the True Human monoclonal antibody therapy, also called 514G3, which is designed to treat all strains of staph infection.
The drug is also expected to be able to beat the strain that’s responsible for MRSA, which is resistant to Methicillin.
“Safety data review from the second dose cohort revealed no dose-limiting toxicities,” John Simard, CEO of XBiotech, said. “We are eager to advance to the final dose cohort and move toward the Phase II portion of the study. This program is representative of an exciting franchise XBiotech is building to treat a variety of life-threatening infectious diseases.”
The 514G3 drug was developed after a human donor with naturally occurring antibodies came forward. The antibodies were shown to beat the strains of MRSA and non-MRSA staph. Furthermore, 514G3 stops the immune evasion and allows white blood cells to find and attack the bacteria.
Researchers expect 514G3 to be delivered without consideration of strain, as it does not appear to have the risks or side effects of antibiotics.
The Phase I/II study will include 52 patients at 16 sites in Europe, Southeast Asia and the U.S.