SPR994: Oral Carbapenem for Treatment of Complicated Urinary Tract Infections
Antibiotic resistance is a growing global health threat, and one especially troubling concern is the rise in resistant strains of E. coli, the bacteria that cause the majority of urinary tract infections (UTIs).
The Center for Disease Dynamics, Economics & Policy (CDDEP) reports that in 2014, the most commonly used oral class of antibiotics for UTI, fluoroquinolones, were experiencing resistance at up to 35% in E. coli. The resistance had more than doubled in the last decade. Spero Therapeutics is developing a novel oral agent to treat these resistant bacteria.
Our most advanced product candidate is SPR994, an oral beta-lactam, which we believe has the potential to become the first oral carbapenem for use in adults. We are developing SPR994 as an oral antibiotic for the treatment of complicated urinary tract infection (cUTI) to help patients avoid hospitalizations (stay at home) and/or transition patients home after IV therapy (get home). Carbapenems have emerged as the standard-of-care for many multidrug-resistant (MDR) Gram-negative bacterial infections, but today they are only available as intravenous therapeutics for such indications.
We announced positive final results from its single ascending dose (SAD) and multiple ascending dose (MAD) Phase 1 clinical trial of SPR994 in healthy volunteers. Based on positive feedback from the FDA Pre-Phase 3 meeting for SPR994, we submitted an Investigational New Drug (IND) application for SPR994 in cUTI with the FDA. We anticipate opening clinical trial sites for the pivotal Phase 3 clinical trial, called ADAPT-PO, to support study enrollment in the first quarter of 2019. The design of our Phase 3 program supports the key value proposition for SPR994 of demonstrating clinical equivalency of an oral versus intravenous carbapenem.