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.
Presentations pertaining to tebipenem HBr and SPR206:
1. Title: Clinical and Microbiological Outcomes for Enterobacterales Uropathogens in the Phase 3 ADAPT-PO Study of Oral Tebipenem Pivoxil Hydrobromide
Presenting Author:
Poster Session: Clinical Trials,
2. Title: Effectiveness of TBP-PI-HBr in Patients with Instrumentation, Anatomic or Functional Abnormalities: Secondary Analysis from ADAPT-PO
Presenting Author:
Poster Session: UTIs,
3. Title: Enterobacterales Resistance Patterns for ESBL+ and MDR Urine Isolates Collected and Tested from 295 Outpatient Facilities in 2019
Presenting Author:
Poster Session: UTIs,
4. Title: The Economic Burden of Adverse Events Requiring Acute Care Services from Outpatient Parenteral Antibiotic Therapy (OPAT) Treatment
Presenting Author:
Poster Session: Social Determinants of Health,
- Selected for oral presentation at the Rapid-Fire Poster Session: Stewardship & Infection Control; Presentation #1488
5. Title: SPR206 Pharmacokinetics (PK) in Plasma, Epithelial Lining Fluid (ELF), and Alveolar Macrophages (AM) in Healthy Adult Subjects
Presenting Author:
Poster Session: PK/PD Studies,
6. Title: Activity of SPR206 and Comparator agents against Pseudomonas aeruginosa and Acinetobacter baumannii Causing Infections in
Presenting Author:
Poster Session: Antimicrobial Novel Agents,
7. Title: In Vitro Activity of SPR206 and Comparator Compounds Against Enterobacterales Isolates Responsible for Infections in
Presenting Author:
Poster Session: Antimicrobial Novel Agents,
About Tebipenem HBr
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 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. 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
Tebipenem HBr Research Support
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.
About SPR206
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 Research Support
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.
About Spero Therapeutics
- Spero Therapeutics is developing SPR720 as a novel investigational oral candidate antimicrobial for the treatment of a rare, orphan pulmonary disease caused by infection with non-tuberculous mycobacteria (NTM-PD).
Spero Therapeutics is developing SPR206 as an investigational IV-administered next-generation polymyxin product candidate developed from its potentiator platform, which is in development to treat MDR Gram-negative infections in the hospital setting.- Tebipenem HBr is an investigational oral carbapenem candidate antimicrobial in development for the treatment of cUTI, including pyelonephritis, including infections caused by MDR pathogens in adult patients who have limited oral treatment options.
For more information, visit https://sperotherapeutics.com.
Forward Looking Statements
This press release may contain forward-looking statements. These statements include, but are not limited to, statements about the future development and commercialization of SPR720, SPR206, and tebipenem HBr; and the design, initiation, timing, progress and results of Spero's preclinical studies and clinical trials and its research and development programs. In some cases, forward-looking statements can be identified by terms such as “may,” “will,” “should,” “expect,” “plan,” “aim,” “anticipate,” “could,” “intent,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including whether tebipenem HBr will advance through the clinical trial process on a timely basis, or at all, taking into account the effects of possible regulatory delays, slower than anticipated patient enrollment, manufacturing challenges, clinical trial design and clinical outcomes; whether the results of such trials will warrant submission for approval from the FDA or equivalent foreign regulatory agencies; whether the FDA will ultimately approve tebipenem HBr and, if so, the timing of any such approval; whether the FDA will require any additional clinical data or place labeling restrictions on the use of tebipenem HBr that would delay approval and/or reduce the commercial prospects of tebipenem HBr; whether a successful commercial launch can be achieved and market acceptance of tebipenem HBr can be established; the lengthy, expensive, and uncertain process of clinical drug development for SPR720 and SPR206; whether results obtained in preclinical studies and clinical trials will be indicative of results obtained in future clinical trials; Spero's reliance on third parties to manufacture, develop, and commercialize its product candidates, if approved; the ability to commercialize Spero's product candidates, if approved; Spero's ability to retain key personnel; whether Spero’s cash resources will be sufficient to fund its continuing operations for the periods and/or trials anticipated; and other factors discussed in the “Risk Factors” set forth in filings that Spero periodically makes with the
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