Tebipenem HBr: Oral Gram-Negative Program

Tebipenem HBr: Oral Carbapenem in Development 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 tebipenem HBr (tebipenem pivoxil hydrobromide; formerly SPR994), an oral beta-lactam, which we believe has the potential to become the first oral carbapenem for use in adults. We are developing tebipenem HBr 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.

Tebipenem HBr 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 tebipenem HBr 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 tebipenem HBr of demonstrating clinical equivalency of an oral versus intravenous carbapenem.  Tebipenem HBr has been granted QIDP designation and has fast track status for the treatment of cUTI and acute pyelonephritis.

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

    In in vitro studies, tebipenem HBr 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, tebipenem HBr 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 tebipenem HBr’s unique oral formulation may enable patients who begin IV treatment in the hospital setting to transition to oral dosing of tebipenem HBr upon patient discharge for convenient home-based care and potentially reduce length of stay in the hospital.

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