University of Texas Medical Branch

• male or females older than 18 years old - Body Weight 40 - 140 kg; - clinical diagnosis of CABP diagnosed less than or equal to 48 hrs after hospital admission; - presence of at least one of the protocol defined SCABP severity criteria: - at least two clinical symptoms - at least 2 vital sign abnormalities - at least one finding of other clinical signs/laboratory abnormalities - radiographic evidence in support of pneumonia with likely bacterial origin - presence of at least one of the following severity criteria based on protocol defined SCABP: - respiratory failure requiring invasive mechanical ventilation support - respiratory failure requiring non-invasive positive pressure ventilation support - respiratory failure requiring high-flow oxygen - septic shock requiring treatment with vasopressors at therapeutic doses for at least 2 hours - requires critical care for management of SCABP - onset of severity criteria less than 48 hours from diagnosis of CABP or upon discussion with medical monitor - written informed consent before any study-specific assessment is performed

Subjects in the hospital who meet any of the following criteria at screening and before study drug administration: - subjects with ventilator-associated pneumonia, aspiration pneumonia, fungal pneumonia, viral pneumonia (viral coinfection may be exempted subject to discussion with medical monitor); - subjects more than 12 hours from the diagnosis of SCABP; - SOFA score greater than 12 points - subject received IV antibiotics for CABP/SCABP for more than 48 hours at the time of randomization if sensitivity supports appropriate empiric therapy chosen and administered - renal replacement therapy - known hypersensitivity to liposomal formulations - end-stage neuromuscular disorders, tracheostomy, known bronchial obstruction, post-operative aspiration pneumonia, cystic fibrosis, known or suspected pneumocystis jirovecii or tuberculosis pneumonia, post organ transplant, or primary or metastatic malignancy in the lungs - current or recent participation in an investigational study (within 30 days of screening or 5 half-lives of the investigational compound, whichever is longer) - known liver dysfunction, chronic liver disease with Child Pugh C or esophageal varices - moribund clinical conditions at the time of screening or time of the first study medication infusion - refractory septic shock at the time of randomization - subject has any medical disease or condition that, in the opinion of the investigator, compromises the subject's safety or compromises the interpretation of results - nursing and pregnant women - women of childbearing potential and non-surgically sterile males