Tebipenem HBr
Tebipenem HBr is an investigational oral carbapenem designed to treat complicated urinary tract infections (cUTI) and acute pyelonephritis (AP). It represents a novel approach in the carbapenem class, aiming to inhibit bacterial cell wall synthesis by binding to penicillin-binding proteins (PBPs), showing activity against resistant bacteria. Spero Therapeutics has granted GSK an exclusive license to commercialize Tebipenem HBr, excluding certain Asian territories. The global, randomized, double-blind Phase 3 clinical trial, PIVOT-PO, began enrollment in January 2024, targeting approximately 2,648 patients with cUTI, with completion expected in the second half of 2025.
SPR206
SPR206 is an investigational intravenous (IV) product candidate aimed at treating multidrug-resistant (MDR) gram-negative infections. It is a next-generation polymyxin analogue developed as a potential treatment option for hospital-acquired or ventilator-associated bacterial pneumonia (HABP/VABP). The FDA cleared Spero's Investigational New Drug (IND) application in February 2024, allowing SPR206 to advance into a Phase 2 clinical trial. Additionally, SPR206 received Fast Track designation by the FDA in March 2024 for the treatment of HABP/VABP caused by carbapenem-resistant Acinetobacter baumannii-calcoaceticus complex and carbapenem-resistant Pseudomonas aeruginosa. Spero plans to initiate a Phase 2 clinical trial, pending non-dilutive funding availability.
SPR720 (currently suspended)
SPR720 is an investigational oral candidate designed to treat Nontuberculous Mycobacterial Pulmonary Disease (NTM-PD), a rare condition. It is a broad-spectrum, once-daily oral treatment that could become the first approved novel oral agent for NTM-PD, addressing a significant unmet need in preventing further lung damage caused by NTM infection. SPR720 is currently being evaluated in a Phase 2a trial, with topline data expected in the fourth quarter of 2024.
