XBiotech, a developer of True Human therapeutic antibodies, announced Tuesday the completion of the first cohort in its Phase 1 of 2 for a clinical study of a novel True Human monoclonal antibody therapy to treat all forms of Staphylococcus aureus infections.
XBiotech will now advance to the next dose level in the Phase 1 portion of the study. The dose, which will be increased by a factor of 5, represents the second of three planned dosing cohorts.
XBiotech's antibody therapy, 514G3, was developed from a human donor with natural antibodies successful at neutralizing MRSA and non-MRSA forms of S. aureus. 514G3 removes the principle immune evasion mechanism of the bacteria and allows white blood cells to detect and destroy the bacteria. Because it is a true Human monoclonal antibody, 514G3 is expected to be well-tolerated without the side effects or risks of antibiotics.
"Review of the safety data from this dose cohort revealed no adverse safety signals, and we are pleased to continue enrolling and dosing patients with 514G3 in accordance with our clinical plan,” XBiotech Medical Director Michael Stecher said. “Based on patient responses to date, we are eager to advance to our next dose cohort."
For more information about the study, visit www.clinicaltrials.gov.