Innoviva Specialty Therapeutics, a subsidiary of Innoviva, Inc. (Nasdaq: INVA) focused on delivering innovative therapies in critical care and infectious disease, today announced that The Lancet Infectious Diseases published detailed results from the pivotal Phase 3 ATTACK trial of sulbactam-durlobactam, the first pathogen-targeted therapy being studied for the treatment of adults with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by susceptible strains of Acinetobacter baumannii-calcoaceticus complex (Acinetobacter). The study – Efficacy and Safety of Sulbactam-Durlobactam vs. Colistin for the Treatment of Patients with Serious Infections due to Acinetobacter Baumannii-Calcoaceticus Complex: a multicentre, randomised, active-controlled, Phase 3, non-inferiority clinical trial (ATTACK) – was first published online on May 11.
“The safety and efficacy demonstrated during the Phase 3 ATTACK trial by sulbactam-durlobactam, which was designed specifically for treating serious infections caused by Acinetobacter, are very promising.” – Keith Kaye, MD, MPH
The Phase 3 trial evaluated the safety and efficacy of sulbactam-durlobactam versus colistin in patients with infections caused by Acinetobacter. In the trial, sulbactam-durlobactam demonstrated statistical non-inferiority versus colistin for the primary endpoint of 28-day all-cause mortality in patients with carbapenem-resistant Acinetobacter infections and a significant difference in clinical cure rates. Sulbactam-durlobactam also exhibited a favorable safety profile with a statistically significant lower incidence of nephrotoxicity as measured by modified Risk–Injury–Failure–Loss and End-stage kidney disease (RIFLE) criteria.
“Serious bacterial infections caused by Acinetobacter baumannii-calcoaceticus complex often result in death, as the pathogen is increasingly resistant to carbapenems and other existing agents,” said Keith Kaye, MD, MPH, Chief, Division of Allergy, Immunology and Infectious Diseases at Rutgers Robert Wood Johnson Medical School. “The safety and efficacy demonstrated during the Phase 3 ATTACK trial by sulbactam-durlobactam, which was designed specifically for treating serious infections caused by Acinetobacter, are very promising, and provide hope that we’ll have a novel, desperately needed, effective treatment option against this lethal pathogen.”
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.
Source: https://www.businesswire.com/
