Spero Therapeutics, Inc. (SPRO) disclosed on Wednesday that it has received approval from the FDA for its investigational new drug (IND) application, to proceed with evaluating SPR206 in a Phase 2 clinical trial.
SPR206 is a novel intravenous polymyxin antibiotic, which is being developed to combat hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) arising from multidrug-resistant Gram-negative bacterial infections.
The upcoming Phase 2 trial will be conducted to gauge the safety, efficacy, and pharmacokinetics of SPR206, when used in tandem with specific antibiotics, for the treatment of HABP or VABP caused by either carbapenem-resistant Acinetobacter baumannii-calcoaceticus complex or carbapenem-resistant Pseudomonas aeruginosa.
The trial will enroll approximately 60 hospitalized adults, who will be treated for a period of 7-14 days. Progress will be assessed based on clinical outcomes post-baseline.
