GSK and Spero Therapeutics Announce Exclusive License Agreement

GlaxoSmithKline (GSK) plc and Spero Therapeutics, Inc. announced entering into a license agreement for tebipenem pivoxil hydrobromide (tebipenem HBr), a carbapenem antibiotic to potentially treat complicated urinary tract infections (cUTIs), including pyelonephritis (kidney infection).

Tebipenem HBr is an oral carbapenem, a broad-spectrum β-lactam antibiotic that acts against Gram-positive and Gram-negative bacteria. It is observed to be very effective in treating drug-resistant bacterial infections.

The FDA declined tebipenem HBr approval in June 2022. Tebipenem HBr was evaluated in a Phase III study (ADAPT-PO, NCT03788967) and compared to ertapenem (intravenous) in patients with cUTIs or acute pyelonephritis. The study concluded that oral tebipenem was non-inferior to IV administered ertapenem and was published in the New England of Medicine. However, the FDA conducted a separate analysis to reduce the number of evaluable patients (in the primary analysis population). Based on their results, it was concluded that the pre-specified non-inferiority margin was not met. Therefore, an additional clinical study would be required to support approval.

GSK would now be supporting Spero to develop and commercialize tebipenem HBr in selected countries. Under the agreement, Spero will execute the remaining Phase III clinical trial of tebipenem HBr, and GSK will be responsible for regulatory submission and commercialization. GSK will pay $66 million up-front, and the remaining payments are milestones-based on the successful completion of the delivery of Phase III program, commercial milestones, and sales milestones. The transaction is anticipated to close in the fourth quarter of 2022, and Spero will initiate a new Phase III clinical trial in 2023.