Spero Therapeutics provides 2024 anticipated milestones

“We look forward to another productive year for Spero in 2024, having achieved important clinical and regulatory milestones over the past twelve months,” said Sath Shukla, President, and CEO of Spero Therapeutics. “We are very pleased to move forward with the PIVOT-PO clinical trial, evaluating tebipenem HBr in complicated urinary tract infections, as we recently began dosing patients. Our Phase 2a trial of SPR720 in nontuberculous mycobacterial pulmonary disease is on track, and we look forward to reporting topline data, which is expected in the second half of 2024. Additionally, we ended 2023 with a strong cash balance, and believe our cash and cash equivalents, together with milestone payments from our tebipenem HBr commercial partner, GSK, will provide runway into late 2025.” 2023 Pipeline Updates and 2024 Anticipated Milestones: SPR720 for Nontuberculous Mycobacterial Pulmonary Disease: In 2H 2024, the company expects to share topline data from the ongoing Phase 2a clinical trial of SPR720, which is being developed as a novel first-line oral treatment for non-tuberculous mycobacterial pulmonary disease. The trial is expected to enroll up to 35 treatment-naive or treatment-experienced non-refractory participants with NTM-PD, due to Mycobacterium avium complex. Tebipenem HBr for complicated urinary tract infections, including acute pyelonephritis: In December 2023, Spero achieved first patient, first visit in PIVOT-PO, the global pivotal Phase 3 clinical trial of tebipenem HBr in patients with complicated urinary tract infections, including acute pyelonephritis, with a target enrollment of approximately 2,648 patients, which we expect to be completed in 2H of 2025. The FDA has indicated that positive and persuasive results from PIVOT-PO, supported with confirmatory evidence of efficacy, could be sufficient to support approval of tebipenem HBr as a treatment for cUTI, including pyelonephritis, for a limited use indication. As part of its license agreement with GSK, Spero is entitled to receive an additional $95 million in development milestone payments, payable in four equal installments over two years. SPR206 for Bacterial Pneumonia: SPR206 is being developed in patients diagnosed with hospital-acquired or ventilator-associated bacterial pneumonia caused by carbapenem-resistant Acinetobacter baumannii-calcoaceticus complex or carbapenem-resistant Pseudomonas aeruginosa.