Spero Announces FDA Clearance Of IND Application For SPR206

(RTTNews) - Spero Therapeutics, Inc. (SPRO) announced on Wednesday that the FDA cleared its investigational new drug or IND application to evaluate SPR206 in a Phase 2 clinical trial.

SPR206 is a new intravenous polymyxin antibiotic intended to address hospital-acquired and ventilator-associated bacterial pneumonia-like HABP/VABP due to multidrug-resistant Gram-negative bacterial infections.

The Phase 2 trial will assess the safety, effectiveness, and pharmacokinetics of SPR206 combined with specific antibiotics to treat HABP or VABP caused by carbapenem-resistant Acinetobacter baumannii-calcoaceticus complex or carbapenem-resistant Pseudomonas aeruginosa.

Around 60 hospitalized adults will be enrolled and treated for 7-14 days, with their progress evaluated based on post-baseline clinical outcomes.