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.

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.

  • 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.

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