(RTTNews) - Spero Therapeutics, Inc. (SPRO), a clinical-stage biopharmaceutical company, on Friday, provided an update on the progress of its clinical pipeline, with a focus on its Phase 3 PIVOT-PO trial for Tebipenem HBr.
The PIVOT-PO trial is evaluating Tebipenem HBr's efficacy in treating complicated urinary tract infections or cUTI and acute pyelonephritis or AP in hospitalized adult patients.
As of December 31, 2024, the Phase 3 PIVOT-PO trial has surpassed 60 percent enrollment. The trial, which aims to enroll approximately 2,648 patients, is on track to complete enrollment by the second half of 2025.
The study compares the oral formulation of Tebipenem HBr to intravenous imipenem-cilastatin, with the primary endpoint being the overall clinical response at the Test-of-Cure visit.
Spero also provided updates on its other ongoing clinical programs.
The Phase 2a trial of SPR720, targeting Non-Tuberculous Mycobacterial-pulmonary disease or NTM-PD, which enrolled 25 patients, did not meet its primary endpoint based on interim analysis. The company is currently analyzing the full data to determine the next steps.
Additionally, Spero has received FDA clearance to initiate a Phase 2 trial of SPR206, a next-generation polymyxin, for hospital-acquired or ventilator-associated bacterial pneumonia (HABP/VABP), contingent upon securing non-dilutive funding.
As of December 31, 2024, Spero reported cash and cash equivalents of $52.9 million, providing the company with a cash runway expected to extend into mid-2026.
SPRO closed Wednesday's (Jan. 08, 2024) trading at $1.00 down 4.76%. In premarket trading Friday, the stock is at $1.00
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