An investigational oral carbapenem being developed for the treatment of complicated urinary tract infection (cUTI) and acute pyelonephritis (AP)
Tebipenem HBr is an investigational, novel, oral antibiotic designed to tackle cUTIs and AP. Tebipenem HBr belongs to the carbapenem class, which inhibits bacterial cell wall synthesis. If approved by the FDA, it would be the first oral carbapenem. By binding to penicillin-binding proteins (PBPs), it showed activity against resistant bacteria. Spero granted GSK an exclusive license to commercialize tebipenem HBr in all territories, except certain Asian territories. Enrollment in PIVOT-PO, a global, randomized, double-blind, Phase 3 clinical trial of tebipenem HBr in patients with cUTI began in January 2024. The trial is expected to enroll approximately 2,648 patients, with enrollment completion targeted for 2H 2025. For more information on the trial, see ClinicalTrials.gov identifier NCT06059846.
Investigational intravenous (IV) product candidate for treating MDR gram-negative infections
SPR206 is a direct-acting IV-administered next-generation polymyxin analogue in clinical development as an innovative potential option to treat MDR gram-negative bacterial infections within the hospital. In February 2024, the U.S. Food and Drug Administration (FDA) cleared the Company's Investigational New Drug (IND) application to advance SPR206 into a Phase 2 clinical trial in participants with hospital-acquired or ventilator-associated bacterial pneumonia (HABP/VABP). In March 2024, SPR206 received Fast Track designation by the FDA for the proposed indication of HABP/VABP due to carbapenem-resistant Acinetobacter baumannii-calcoaceticus complex ("CRABc") and carbapenem-resistant Pseudomonas aeruginosa ("CRPA"). Spero plans to initiate a Phase 2 clinical trial contingent on the availability of non-dilutive funding.
An investigational oral candidate designed to treat Nontuberculous Mycobacterial Pulmonary Disease (NTM-PD), a rare disease
SPR720 is a broad spectrum, oral candidate that, if approved, would be a once daily oral treatment for patients with NTM-PD. SPR720 has the potential to be the first approved novel oral agent for NTM-PD, addressing a significant unmet need to treat infection and help prevent further lung damage that the NTM infection causes. SPR720 is currently being evaluated in a Phase 2a trial. For more information on the trial, see ClinicalTrials.gov identifier NCT05496374. Topline data from the Phase 2a proof of concept clinical trial are expected in 4Q 2024.
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