Atox Bio announced that the FDA has granted Fast Track designation to AB103, currently in development for the treatment of necrotizing soft tissue infections (NSTI).

Atox Bio completed recruitment of 40 patients in a Phase 2 proof of concept study evaluating AB103’s clinical benefit when administered in addition to standard of care. Efficacy data from these 40 patients is expected by the end of this year.

AB103 is a rationally designed short peptide acting as a CD28 modulator regulating the host’s inflammatory response, improving the host’s ability to effectively fight the infection. This mode of action provides a unique approach to treating infectious diseases by targeting the host’s immune system, rather than the pathogen, thereby providing solution for bacterial infections with broad-spectrum coverage, independent of pathogen type and eliminating the risk of drug resistance.

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