Spero Therapeutics, a clinical-stage biopharmaceutical company, announced that its Phase 3 PIVOT-PO trial evaluating Tebipenem HBr for complicated urinary tract infections (cUTI) and acute pyelonephritis (AP) has reached over 60% enrollment as of December 31, 2024. The company anticipates completing enrollment, targeting approximately 2,648 patients, by the second half of 2025.
The PIVOT-PO trial is a randomized, double-blind study comparing oral Tebipenem HBr to intravenous imipenem-cilastatin in hospitalized adult patients with cUTI and AP. The primary endpoint is the overall clinical response at the Test-of-Cure (TOC) visit, assessing both clinical cure and favorable microbiological response. Tebipenem HBr is an investigational oral carbapenem antibiotic. If approved, it would provide an oral alternative to IV antibiotics, addressing unmet medical needs and potentially reducing hospitalizations.
SPR720 and SPR206 Updates
Spero's Phase 2a trial of SPR720 for Non-Tuberculous Mycobacterial-Pulmonary Disease (NTM-PD), which enrolled 25 patients, did not meet its primary endpoint based on interim analysis. The company is analyzing the full data to determine the next steps. Furthermore, the FDA has cleared Spero to initiate a Phase 2 trial of SPR206, a next-generation polymyxin, for hospital-acquired or ventilator-associated bacterial pneumonia (HABP/VABP), contingent on securing non-dilutive funding.
Leadership Transition
In response to a Wells Notice from the SEC related to certain public disclosures in 2022, Spero Therapeutics has appointed Esther Rajavelu as Interim President and Chief Executive Officer, replacing Sath Shukla, who will take a voluntary paid administrative leave. Frank Thomas has been appointed Chairman of the Board, succeeding Dr. Ankit Mahadevia. According to Frank Thomas, Chairman of the Board of Spero Therapeutics, "The Board is highly confident that Esther is well equipped to serve as Interim President and CEO and execute on the Company’s strategy to advance our pipeline during this period."
Financial Status
As of December 31, 2024, Spero reported cash and cash equivalents of $52.9 million, which is expected to fund operations into mid-2026. According to Ms. Esther Rajavelu, Interim President and Chief Executive Officer of Spero Therapeutics, "Our cash runway into mid-2026 enables us to stay focused on our highest priority, the tebipenem clinical program and other ongoing activities."
