Clinical TrialsSpero's third candidate, SPR206, has received Investigational New Drug (IND) clearance from the FDA to enter a Phase 2 clinical trial in patients with hospital- or ventilator-acquired pneumonia (HAP/VAP).
FDA Approval PotentialThe FDA has indicated that positive and persuasive results from PIVOT-PO, along with data from prior studies, could be sufficient to support approval of tebipenem HBr in complicated urinary tract infections (cUTIs), including pyelonephritis, for a limited use indication.
Pipeline MaturityThe company's pipeline continues to mature, with tebipenem HBr advancing in the PIVOT-PO Phase 3 confirmatory trial and SPR720 being assessed in a Phase 2a trial in treatment-naive and pulmonary disease (NTM-PD) patients.