Spero Therapeutics

GSK and Spero Therapeutics announced the pivotal Phase III PIVOT-PO trial for tebipenem HBr was stopped early for efficacy following a recommendation from an Independent Data Monitoring Committee based on data from 1,690 patients.

DelveInsight's 2025 pipeline analysis reveals 12+ pharmaceutical companies actively developing therapies for complicated urinary tract infections, with several candidates in advanced clinical stages.

GSK's phase 3 PIVOT-PO trial for tebipenem HBr was stopped early after an independent monitoring committee determined the oral carbapenem antibiotic was at least as effective as intravenous treatment for complicated urinary tract infections.

Spero Therapeutics' Phase 3 PIVOT-PO trial for Tebipenem HBr has surpassed 60% enrollment as of December 31, 2024, and is on track for completion in the second half of 2025.

• Several pharmaceutical and biotech companies are actively developing novel therapies for complicated urinary tract infections (cUTIs). • Spero Therapeutics' Tebipenem Pivoxil Hydrobromide is in Phase III clinical trials, representing a late-stage advancement in cUTI treatment. • Other companies like Iterum Therapeutics and Venatorx are also contributing to the cUTI therapeutics market with drugs like Sulopenem. • Emerging therapies cover various routes of administration, molecule types, and mechanisms of action, offering diverse treatment options.

• Spero Therapeutics' Phase 3 PIVOT-PO trial of tebipenem HBr for complicated urinary tract infections remains on track, with enrollment expected to complete in the second half of 2025. • The company has suspended development of SPR720 for nontuberculous mycobacterial pulmonary disease after interim analysis showed insufficient separation from placebo. • Spero's SPR206 program, targeting multi-drug resistant Gram-negative pathogens, is ready for Phase 2 trials, contingent on securing non-dilutive funding. • With a restructuring and reduction in force, Spero Therapeutics extends its cash runway into mid-2026, supported by a Q3 2024 cash balance of $76.3M.

• Spero Therapeutics discontinued the development of SPR720 after it failed to meet the primary endpoint in a Phase IIa trial for non-tuberculous mycobacterial pulmonary disease (NTM-PD). • The interim analysis of SPR720 showed no significant antimicrobial effect compared to placebo, leading to the suspension of the program and a 39% staff reduction. • Spero will now prioritize tebipenem HBr, licensed to GSK, and SPR206, with ongoing trials and FDA clearance for Phase II contingent on funding. • The company's stock price declined following the announcement, reflecting investor concerns about the future of its antibiotic pipeline.

• Spero Therapeutics discontinued the development of SPR720 after it failed to meet the primary endpoint in a Phase IIa trial for non-tuberculous mycobacterial pulmonary disease (NTM-PD). • The interim analysis of the trial showed no significant antimicrobial effect compared to placebo, leading to the suspension of the SPR720 program. • Spero plans to focus on its other antibiotic programs, including tebipenem HBr and SPR206, while also reducing its workforce by 39% to extend its cash runway. • The company's stock price declined by over 17% following the announcement, reflecting investor concerns about the future of the SPR720 program.

• Spero Therapeutics suspends SPR720 development for NTM-PD after Phase 2a trial fails to demonstrate sufficient separation from placebo in interim analysis. • The Phase 2a trial showed antimicrobial activity but raised safety concerns, including reversible grade 3 hepatotoxicity at the 1,000mg dose. • Spero will restructure operations, reducing workforce by 39% to extend cash runway into mid-2026 and focus on tebipenem HBr and SPR206. • The company remains committed to advancing tebipenem HBr in its Phase 3 trial for cUTI and preparing for a Phase 2 trial for SPR206, pending funding.

Spero Therapeutics successfully defended against a proposed investor class action alleging the company concealed information regarding the regulatory approval prospects of one of its drugs.