XBiotech of Austin, Texas, a developer of next-generation True Human therapeutic antibodies, was granted Fast Track Designation from the U.S. Food and Drug Administration recently for its True Human monoclonal antibody therapy.
True Human is being developed to treat all forms of staphylococcus aureus infections. The company's antibody therapy, 514G3, is currently being evaluated in a Phase 1/2 clinical study, and was developed from a human donor with natural antibodies effective at neutralizing Methicillin-resistant Staphylococcus aureus (MRSA) and non-MRSA forms of S. aureus.
The 514G3 antibody has been found to eliminate the principle immune evasion mechanism of the bacteria, allowing white blood cells to detect and destroy it. XBiotech said it will be well tolerated without the side effects or risks of antibiotics.
"Receiving FDA Fast Track Designation highlights the importance for this product candidate to treat life-threatening bacterial infections," John Simard, Biotech's chief executive officer, said.
Fast Track Designation will expedite clinical development and regulatory review. It's usually given to drugs designed to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs.