SPR994: Oral Gram-Negative Program

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.

SPR994 is currently being assessed in a single pivotal Phase 3 clinical trial in complicated urinary tract infection (cUTI) entitled ADAPT-PO.  The clinical trial is designed as a double-blind, double-dummy trial to compare oral SPR994 with an existing standard of care intravenous (IV) antibiotic, ertapenem, in approximately 1,200 patients with cUTI or acute pyelonephritis, randomized 1:1 in each arm.  The design of our Phase 3 program supports the key value proposition for SPR994 of demonstrating clinical equivalency of an oral versus intravenous carbapenem.  SPR994 has been granted QIDP designation and has fast track status for the treatment of cUTI and acute pyelonephritis.

  • Broad spectrum activity against a wide variety of multidrug-resistant Gram-negative, Gram-positive and anaerobic bacteria.

    In in vitro studies, SPR994 demonstrated potent antibacterial activity against Gram-negative bacteria, including ESBL-producing E. coli and ESBL-producing Klebsiella pneumoniae.

  • Convenient dosing regimen to avoid hospitalization.

    Unlike other medications to treat these resistance bacteria in adults, which are only available as intravenous infusions, SPR994 is an orally administered tablet. Oral administration may allow physicians to avoid intravenous antibiotics for an otherwise healthy or stable patient and/or allow for a reduction in costs associated with avoiding hospitalization altogether.

  • Potential for convenient IV-to-oral transition to assist with getting patients out of the hospital and reduce length of stay.

    We believe SPR994’s unique oral formulation may enable patients who begin IV treatment in the hospital setting to transition to oral dosing of SPR994 upon patient discharge for convenient home-based care and potentially reduce length of stay in the hospital.

  • Investors

    Learn about the investment opportunity, see our upcoming events and download our latest corporate presentation.  

    Investment opportunities >
  • Careers

    Join a passionate team that pushes the limits in finding innovative therapies to help patients. Named one of Boston’s Best Places to Work.

    Career opportunities >
  • Partners

    Our strategic partnerships foster mutually beneficial alliances that advance medicine to improve patient lives.

    Partnership opportunities >