Armata Pharmaceuticals (NYSE American: ARMP) has announced that the FDA has granted Breakthrough Therapy designation to AP-SA02, its intravenously administered Staphylococcus aureus multi-phage product candidate, for adjunct treatment of complicated bacteremia caused by methicillin-sensitive Staphylococcus aureus (MSSA) or methicillin-resistant Staphylococcus aureus (MRSA).
According to Armata, the designation was driven by compelling Phase 2 clinical data in patients with complicated Staphylococcus aureus bacteremia showing AP-SA02 may offer substantial improvement over available therapies.
In a statement, Dr. Deborah Birx, CEO of Armata, commented, “The decision by the FDA to grant Breakthrough Therapy designation to AP-SA02, in addition to Qualified Infectious Disease Product (QIDP), and Fast Track designations, recognizes the urgent need for new treatment options for patients with complicated Staphylococcus aureus bacteremia (SAB), including MRSA, where many outcomes remain poor despite current standard-of-care.”
Dr. Birx added, “Based on the Phase 2 clinical trial data, we believe AP-SA02 has the potential to represent an important advancement in the treatment of complicated SAB, a serious bloodstream infection that continues to be associated with significant relapse rate, morbidity and mortality. If ultimately confirmed in Phase 3 and approved, AP-SA02 has the potential to become the first antibacterial therapy approved based on superiority to current standard-of-care treatment in this patient population. We are grateful for the FDA’s enhanced engagement and are committed to working closely with the agency to efficiently advance the development and review of AP-SA02, with the goal of bringing this potential new treatment option to patients as quickly as possible.”
