Spero Therapeutics to Present Data for All Pipeline Programs at IDWeek 2020 October 16, 2020 15 data presentations cover each of Spero’s three pipeline programs and include a late breaker oral presentation on the Phase 3 ADAPT-PO clinical trial CAMBRIDGE, Mass., Oct. 16, 2020 (GLOBE NEWSWIRE) -- Spero Therapeutics, Inc. (Nasdaq: SPRO), a multi-asset clinical-stage biopharmaceutical company focused on identifying, developing and commercializing treatments in high unmet need areas involving multi-drug resistant bacterial infections and rare diseases, today announced that it will have 15 data presentations at the Infectious Disease Society of America (IDSA) IDWeek™ 2020 taking place virtually from October 21 - 25, 2020. Presentations will cover each of Spero’s three pipeline programs and include a late breaker oral presentation on the Phase 3 ADAPT-PO clinical trial that evaluated Spero’s oral antibiotic investigational candidate, tebipenem HBr, for the treatment of adults with complicated urinary tract infection (cUTI) and acute pyelonephritis (AP). In September 2020, Spero announced positive top-line data from the trial demonstrating that oral tebipenem HBr was statistically non-inferior to intravenous (IV) ertapenem in the treatment of patients with cUTI and patients with AP. Poster presentations include a poster on the Phase 1 clinical trial of SPR720, an oral antimicrobial investigational agent in clinical development by Spero for the treatment of nontuberculous mycobacterial (NTM) pulmonary disease. In December 2019, Spero announced positive data from this Phase 1 double-blind, placebo-controlled single ascending dose and multiple ascending dose clinical trial in healthy volunteers. Presentations pertaining to tebipenem HBr and the epidemiology and management of cUTI: Title: Oral Tebipenem Pivoxil Hydrobromide is Non-inferior to IV Ertapenem in Complicated Urinary Tract Infection (cUTI) and Acute Pyelonephritis (AP) – Results from the Pivotal ADAPT-PO Study Presenting Author: Paul Eckburg Date: Saturday, October 24, 2020 Time: 10:00 – 11:15 AM EDT Title: Characterization of Tebipenem Pivoxil Hydrobromide Pharmacokinetics-Pharmacodynamics (PK-PD) in a Neutropenic Murine Acute Pyelonephritis (AP) Model Presenting Author: Brian D. VanScoy Date: Wednesday, October 21, 2020 Poster Session: PK/PD Studies Poster Number: 1304 Title: Tebipenem: An Oral Carbapenem with Activity Against Multi-drug Resistant Urinary Tract Infection Isolates of Escherichia coli Collected from US Medical Centers During 2019 Presenting Author: Ian A. Critchley Date: Wednesday, October 21, 2020 Poster Session: UTIs Poster Number: 1695 Title: Epidemiology of Complicated Urinary Tract Infections (cUTIs) Presenting in Emergency Departments Across the United States (US) Presenting Author: Thomas Lodise Date: Wednesday, October 21, 2020 Poster Session: UTIs Poster Number: 1673 Title: Hospital Admission Patterns in Adult Patients with Complicated Urinary Tract Infections (cUTIs): Identification of Potentially Avoidable Hospital Admissions Across United States (US) Hospitals Presenting Author: Thomas Lodise Date: Wednesday, October 21, 2020 Poster Session: UTIs Poster Number: 1683 Title: Hospital Costs and Reimbursement in Patients with Resistant Enterobacteriaceae (ENT) Urinary Tract Infection (UTI) in the United States (US): A Multicenter Analysis Presenting Author: Katherine Sulham Date: Wednesday, October 21, 2020 Poster Session: UTIs Poster Number: 1684 Title: Eligibility and Outcomes of Conversion to Oral (PO) Therapy in Patients Hospitalized with Enterobacteriaceae (ENT) Urinary Tract Infection (UTI) in the United States (US): A Multicenter Analysis Presenting Author: Katherine Sulham Date: Wednesday, October 21, 2020 Poster Session: UTIs Poster Number: 1672 Title: Pre- and Post-Hospitalization Resource Utilization and Costs Associated with Urinary Tract Infection (UTI) in both Commercial and Medicare Populations Presenting Author: Katherine Sulham Date: Wednesday, October 21, 2020 Poster Session: UTIs Poster Number: 1691 Title: Health Resource Utilization in Patients with Complicated Urinary Tract Infections (cUTI) and Antibiotic Resistance or Treatment Failure: A Retrospective Database Analysis Presenting Author: Katherine Sulham Date: Wednesday, October 21, 2020 Poster Session: UTIs Poster Number: 1682 Title: Clinical Characteristics and Demographics of Patients with Complicated Urinary Tract Infections (cUTI) and Antibiotic Resistance or Treatment Failure: A Retrospective Database Analysis Presenting Author: Katherine Sulham Date: Wednesday, October 21, 2020 Poster Session: UTIs Poster Number: 1670 Presentations pertaining to SPR720, Spero’s novel investigational oral antibacterial agent that targets enzymes essential for bacterial DNA replication: Title: Phase 1 First-in-Human Single- and Multiple-Ascending Dose Trial Demonstrates Pharmacokinetics (PK) and Tolerability of SPR720, an Oral DNA GyrB Inhibitor for Mycobacterial Infections Presenting Author: Angela Talley Date: Wednesday, October 21, 2020 Poster Session: Novel Agents Poster Number: 1288 Title: SPR720, A Novel Benzimidazole Gyrase Inhibitor, Demonstrates Potent Efficacy Against Mycobacterium avium ATCC 700898 in a Chronic C3HeBFeJ Mouse Infection Model Presenting Author: Nicole S. Cotroneo Date: Wednesday, October 21, 2020 Poster Session: Tuberculosis and other Mycobacterial Infections Poster Number: 1637 Title: Evaluating the Activity of SPR719, a Novel Aminobenzimidazole, against Nontuberculous Mycobacteria Presenting Author: Chris Pillar Date: Wednesday, October 21, 2020 Poster Session: Novel Agents Poster Number: 1274 Title: Pharmacokinetics/pharmacodynamics of the Novel Gyrase Inhibitor SPR719/SPR720 and Clinical Dose Selection to Treat Pulmonary Mycobacterium avium-complex Disease Presenting Author: Tawanda Gumbo Date: Wednesday, October 21, 2020 Poster Session: Tuberculosis and other Mycobacterial Infections Poster Number: 1659 Presentations pertaining to SPR206, Spero’s next generation polymyxin investigational product candidate being developed to treat multi-drug resistant (MDR) Gram-negative infections in the hospital setting: Title: Activity of SPR206, a Polymyxin B derivative, Compared to Colistin Alone and in Combination Against Multidrug-Resistant Pseudomonas aeruginosa Strains Presenting Author: Jacinda C. Abdul-Mutakabbir Date: Wednesday, October 21, 2020 Poster Session: PK/PD studies Poster Number: 1295 Abstracts are accessible via the IDWeek™ website. Poster presentations may be accessed through Spero Therapeutics’ website on the “Key Publications and Presentations” page under the “Pipeline” tab following their completion. About Tebipenem HBr Tebipenem HBr (tebipenem pivoxil hydrobromide; formerly SPR994) is Spero’s novel investigational oral formulation of tebipenem pivoxil, a carbapenem antibiotic of the β-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. Orapenem® is not approved in the U.S. 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 AP. Spero expects to submit a New Drug Application submission to the U.S. Food and Drug Administration (FDA) for tebipenem HBr in the second quarter of 2021. If approved, tebipenem HBr would be the first oral carbapenem to receive marketing approval in the United States. Tebipenem HBr has been granted Qualified Infectious Disease Product (QIDP) and Fast Track designations by the FDA for the treatment of cUTI and AP. About SPR720 SPR720 represents a novel class of antibacterial agents in development that target enzymes essential for bacterial DNA replication. SPR720, an investigational new drug, was acquired from Vertex Pharmaceuticals and is currently under clinical development by Spero as an oral therapy for the treatment of non-tuberculous mycobacterial (NTM) pulmonary disease, a rare chronic orphan disease. Spero plans to initiate enrollment in its planned Phase 2a clinical trial evaluating SPR720 in patients with NTM pulmonary disease by year-end 2020. Non-tuberculous mycobacteria are ubiquitous environmental pathogens that can cause progressive lung damage and respiratory failure, particularly in patients with compromised immune systems or underlying pulmonary disorders. Although rare, the incidence of NTM pulmonary disease is increasing worldwide. Treatment of NTM pulmonary disease requires prolonged therapy (continuing for approximately 12 to 24 months) with a combination of drugs approved for other infections and is frequently complicated by tolerability and/or toxicity issues. There are currently no oral antibiotics specifically approved for use to treat NTM pulmonary disease. Thus, if successfully developed and approved by the FDA, SPR720 has the potential to address an important unmet need as the first oral antibiotic approved for the treatment of this debilitating disease. Under Spero’s collaboration with the Bill and Melinda Gates Medical Research Institute, SPR720 will also be developed for the treatment of Mycobacterium tuberculosis (M. tb) infections in select economically disadvantaged countries. M. tb is a priority pathogen as defined by the World Health Organization with tuberculosis being one of the top ten causes of death worldwide and associated with both increasing resistance and sub-optimal