Spero announces first patient, first visit for Phase 3 PIVOT-PO trial

Spero Therapeutics (SPRO) announced the first patient, first visit for PIVOT-PO, a global pivotal Phase 3 clinical trial of tebipenem HBr in patients with complicated urinary tract infections, cUTI, including acute pyelonephritis. Spero is entitled to receive $95 million in development milestone payments from GSK (GSK), which is payable in four equal installments over two years. “First patient visit, in the PIVOT-PO Phase 3 clinical trial, is an important milestone in our tebipenem HBr program,” said Sath Shukla, President and CEO of Spero Therapeutics. “We are developing Tebipenem HBr to potentially be the first oral broad-spectrum carbapenem in the U.S. for use in patients with cUTI. Oral administration may provide physicians with an alternative to hospital-based IV therapy, for appropriate patients, with potential value to the broader healthcare system.”