Spero Therapeutics, Inc. announced data presentations for 7 abstracts accepted at the Infectious Disease Society of America (IDSA) IDWeek™ 2022, taking place from October 19 – 23, 2022 in Washington, DC. Spero-affiliated presentations will showcase clinical and nonclinical data for tebipenem HBr, Spero's oral antibiotic investigational candidate in development for the treatment of adults with complicated urinary tract infection (cUTI), including pyelonephritis, along with health outcomes and epidemiologic data highlighting the potential utility of tebipenem HBr to address unmet medical need. SPR206 will also figure prominently with in vitro analysis of target pathogens and clinical isolates, along with clinical data for SPR206 in healthy adult subjects supportive of further development in the treatment of pulmonary infections.

Tebipenem HBr (tebipenem pivoxil hydrobromide; formerly SPR994) is Spero's novel late-stage development asset, an oral formulation of tebipenem pivoxil, a carbapenem antibiotic of the ß-lactam class marketed by Meiji Seika Pharma Co. Ltd. (Meiji) in Japan as Orapenem® since 2009 for pediatric infections limited to pneumonia, otitis media and sinusitis. Carbapenems are an important subclass of antibiotics because they have been observed to be safe and effective in the treatment of drug-resistant Gram-negative bacterial infections.

Tebipenem HBr is being developed for the treatment of cUTI, including acute pyelonephritis (AP), caused by certain bacteria. If approved, tebipenem HBr would be the first oral carbapenem antimicrobial to receive marketing approval in the United States. The U.S. Food and Drug Administration (FDA) has granted tebipenem HBr Qualified Infectious Disease Product (QIDP) designation, for the treatment of cUTI, community-acquired pneumonia (CABP) and diabetic foot infections (DFI), and Fast Track designations for the treatment of cUTI and AP.

Following feedback from the FDA at Spero's recent Type A meeting, Spero will conduct an additional Phase 3 trial to support the potential approval of tebipenem HBr. Select tebipenem HBr studies have been funded in part with federal funds from the Department of Health and Human Services; Office of the Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority, under contract number HHSO100201800015C. SPR206 is an IV-administered next generation polymyxin product candidate designed to act directly on Gram-negative bacterial infections through the molecule's interactions with the bacterial outer membrane.

In pre-clinical studies, SPR206 has demonstrated potent broad-spectrum activity against Gram-negative bacteria, including organisms identified by the Centers for Disease Control and Prevention and the World Health Organization as urgent and serious threats to human health. Spero has completed a first-in-human Phase 1 assessment of SPR206 in which the product candidate was generally well-tolerated and demonstrated no evidence of nephrotoxicity at anticipated therapeutic doses. A Phase 1 bronchoalveolar lavage (BAL) clinical trial assessing the penetration of SPR206 into the pulmonary compartment and a Phase 1 renal impairment clinical trial of SPR206 have been completed.

SPR206 has been granted QIDP designation by the FDA for the treatment of cUTI and hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP). SPR206 clinical trials have been supported by the Office of the Assistant Secretary of Defense for Health Affairs, through the Joint Warfighter Medical Research Program under Award No. W81XWH1910295.

Opinions, interpretations, conclusions, and recommendations are those of the author and are not necessarily endorsed by the Department of Defense. The U.S. Army Medical Research Acquisition Activity, 839 Chandler Street, Fort Detrick MD 21702-5014 is the awarding and administering acquisition office.