PRODUCTUTEBZI (tebipenem HBr)

UTEBZI (tebipenem HBr) is the first and only oral carbapenem for the treatment of complicated UTI (cUTI), including pyelonephritis, caused by susceptible pathogens in adults. The product’s approval was based on the PIVOT-PO trial, which demonstrated non-inferiority when compared to intravenous treatment. More than 3 million cases of cUTIs are treated annually in the US with a third of patients impacted by resistant infections.

Background

Spero Therapeutics (“Spero”) sought to pivot the company from its anti-infectives roots into an immunology-focused company. Concurrently with a licensing agreement with Innovent, Spero monetized the majority of the payments relating to UTEBZI that it will receive from GSK in a financing transaction with HealthCare Royalty. The proceeds enabled Spero to meaningfully extend cash runway even while funding the upfront licensing of SP001, a Phase 2-ready, Fc-silent, third-generation anti-CD40L monoclonal antibody with potential for development across a range of immune-mediated diseases.