Armata says FDA grants Breakthrough Therapy designation for AP-SA02 in complicated Staph aureus bacteremia
ARMP•Clinical results and development outlook
AP-SA02 showed better overall patient outcomes than placebo when added to best-available antibiotics, with fewer relapses during follow-up.
Regulatory status strengthens the program’s development outlook, with Fast Track and QIDP designations already in place.
The company positioned AP-SA02 as a potential first-in-class therapy to demonstrate superiority versus current standard care if confirmed in Phase 3.
FDA grants Breakthrough Therapy designation
Armata Pharmaceuticals received FDA Breakthrough Therapy designation for AP-SA02 in adjunct treatment of complicated Staphylococcus aureus bacteremia.
The designation was supported by results already presented from a Phase 1b/2a study in adults with complicated bloodstream infection.
