Results from Pivotal Phase 3 ATTACK Trial of Investigational Sulbactam-Durlobactam for Treatment of Serious Infections Caused by Acinetobacter Published in The Lancet Infectious Diseases - Seite 2

Infections caused by drug-resistant Acinetobacter are serious and life-threatening conditions associated with high morbidity and mortality¹ and long, expensive hospital stays. Acinetobacter is resistant to penicillins and has also acquired resistance genes for almost all antibiotics used to treat Gram-negative bacteria, including fluoroquinolones, aminoglycosides, cephalosporins, and carbapenems.

The Centers for Disease Control and Prevention (CDC) has identified carbapenem-resistant micro-organisms as an urgent threat². Globally, Acinetobacter baumannii was among the top six leading pathogens for deaths associated with resistance in 2019³. Carbapenem-resistant Acinetobacter is considered a Priority 1 pathogen by the World Health Organization (WHO)⁴.

The New Drug Application (NDA) for sulbactam-durlobactam, filed by Entasis Therapeutics Inc., an affiliate of Innoviva Specialty Therapeutics, is currently under Priority Review by the U.S. Food and Drug Administration (FDA). On April 17, 2023, the FDA’s Antimicrobial Drugs Advisory Committee (AMDAC) voted unanimously 12-0 in support of approval based on a favorable benefit-risk assessment of sulbactam-durlobactam for the treatment of adults with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by susceptible strains of Acinetobacter. The sulbactam-durlobactam NDA has a Prescription Drug User Fee Act (PDUFA) target action date of May 29, 2023.

About Acinetobacter
Members of the Acinetobacter baumannii-calcoaceticus complex (Acinetobacter) are Gram-negative, opportunistic human pathogens that predominantly infect critically ill patients often resulting in severe pneumonia and bloodstream infections. They can also infect other body sites, such as the urinary tract and the skin. Acinetobacter is considered a global threat in the healthcare setting due in part to its ability to acquire multidrug resistance.

In the U.S., there are an estimated 40,000 to 80,000 cases of Acinetobacter each year⁵, and about 40 percent of those are carbapenem-resistant Acinetobacter⁶. Globally, there are about a million cases each year of Acinetobacter, and about two-thirds of those are carbapenem-resistant Acinetobacter baumannii⁵. More than 300,000 global deaths annually are associated with carbapenem-resistant Acinetobacter⁷.

About sulbactam-durlobactam
Sulbactam-durlobactam is an intravenous, or IV, investigational drug that is a combination of sulbactam, a beta-lactam antibacterial, and durlobactam, a beta-lactamase inhibitor, being developed for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by susceptible strains of Acinetobacter baumannii-calcoaceticus complex (Acinetobacter). Sulbactam-durlobactam has been designated a Qualified Infectious Disease Product by the FDA, a designation that aims to spur development of new antibiotics for serious and life-threatening infections. In November 2022, the FDA accepted the New Drug Application (NDA) for sulbactam-durlobactam for Priority Review and set a Prescription Drug User Fee Act (PDUFA) target date of May 29, 2023.