Spero Therapeutics to Present Data for All Pipeline Programs at IDWeek 2020
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
Title: Characterization of Tebipenem Pivoxil Hydrobromide Pharmacokinetics-Pharmacodynamics (PK-PD) in a Neutropenic Murine Acute Pyelonephritis (AP) Model
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
Title: Epidemiology of Complicated Urinary Tract Infections (cUTIs) Presenting in Emergency Departments Across the United States (US)
Title: Hospital Admission Patterns in Adult Patients with Complicated Urinary Tract Infections (cUTIs): Identification of Potentially Avoidable Hospital Admissions Across United States (US) Hospitals
Title: Hospital Costs and Reimbursement in Patients with Resistant Enterobacteriaceae (ENT) Urinary Tract Infection (UTI) in the United States (US): A Multicenter Analysis
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
Title: Pre- and Post-Hospitalization Resource Utilization and Costs Associated with Urinary Tract Infection (UTI) in both Commercial and Medicare Populations
Title: Health Resource Utilization in Patients with Complicated Urinary Tract Infections (cUTI) and Antibiotic Resistance or Treatment Failure: A Retrospective Database Analysis
Title: Clinical Characteristics and Demographics of Patients with Complicated Urinary Tract Infections (cUTI) and Antibiotic Resistance or Treatment Failure: A Retrospective Database Analysis
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
Title: SPR720, A Novel Benzimidazole Gyrase Inhibitor, Demonstrates Potent Efficacy Against Mycobacterium avium ATCC 700898 in a Chronic C3HeBFeJ Mouse Infection Model
Title: Evaluating the Actiity of SPR719, a Novel Aminobenzimidazole, against Nontuberculous Mycobacteria
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
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
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
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 current treatment approaches.
SPR720 has been granted QIDP designation by the FDA for the treatment of lung infections caused by NTM and lung infections caused by M. tb and Orphan Drug Designation by the FDA for the treatment of NTM infection.
Tebipenem HBr Research Support
SPR720 Research Support
SPR206 Research Support
Non-clinical research for the SPR206 program is funded in part with Federal funds from the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services, under Contract No. HHSN272201500014C.
Non-clinical research for the SPR206 program was funded in part by The U.S. Army Medical Research Acquisition Activity, 820 Chandler Street, Fort Detrick MD 21702-5014, which is the awarding and administering acquisition office. This work was supported in part by the Office of the Assistant Secretary of Defense for Health Affairs, through the Peer Reviewed Medical Research Program under Award No. W81XWH-16-2-0019. Opinions, interpretations, conclusions and recommendations are those of the author and are not necessarily endorsed by the Department of Defense.
About Spero Therapeutics
Spero’s lead product candidate, tebipenem HBr (tebipenem pivoxil hydrobromide; formerly SPR994), is being developed as the first oral carbapenem antibiotic for use in complicated urinary tract infections (cUTI) and acute pyelonephritis (AP). In September 2020, Spero announced positive top-line results from its Phase 3 ADAPT-PO clinical trial of tebipenem HBr in cUTI and AP.
Spero is also advancing SPR720, its novel oral therapy product candidate being developed for the treatment of rare, orphan pulmonary disease caused by non-tuberculous mycobacterial (NTM) infections.
Spero also has an IV-administered next generation polymyxin product candidate, SPR206, developed from its potentiator platform that is being developed to treat MDR Gram-negative infections in the hospital setting.
For more information, visit?https://sperotherapeutics.com.
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