Press Release
XBiotech Enrolls Final Patient in Phase I Portion of Clinical Study of Novel True Human™ Therapeutic Antibody for Treating Serious Infections Due to Staphylococcus aureus
The Phase I portion involved dose escalation to establish a safe dose-level to use during the Phase II expansion. The Phase I portion of the study will not be complete until the last patient enrolled is found to be free of dose-related toxicities. The Phase II portion of the trial will then commence and include a larger cohort of patients that will be used to further investigate safety and efficacy of the therapy.
XBiotech’s novel antibody therapy, known as 514G3, was developed from a human donor with natural antibodies effective at neutralizing MRSA and non-MRSA forms of S. aureus. 514G3 knocks out the principle immune evasion mechanism of the bacteria, allowing white blood cells to detect and destroy the bacteria. 514G3 is expected to treat all strains of MRSA and can be used without consideration for strain-specific resistance to various antibiotics. As a True Human monoclonal antibody, 514G3 is expected to be well tolerated without the side effects or risks of antibiotics.
The randomized, placebo-controlled, Phase 1/2 study is designed to evaluate dosing, safety and efficacy of 514G3 and will enroll 52 patients at approximately 16 clinical sites in
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Contact:Ashley Otero XBiotech aotero@xbiotech.com 512.386.2930