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CAMBRIDGE, Mass., Oct. 19, 2022 (GLOBE NEWSWIRE) — Spero Therapeutics, Inc. SPRO, a multi-asset clinical-stage biopharmaceutical company, focused on identifying, developing and commercializing treatments in high unmet need areas involving rare diseases and multi-drug resistant (MDR) bacterial infections, today 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.
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: Ian A. Critchley, PhD (Spero Therapeutics)
Poster Session: Clinical Trials, October 20, 2022; 12:15PM-1:30PM US ET; Poster #222
2. Title: Effectiveness of TBP-PI-HBr in Patients with Instrumentation, Anatomic or Functional Abnormalities: Secondary Analysis from ADAPT-PO
Presenting Author: Angela K. Talley, MD (Spero Therapeutics)
Poster Session: UTIs, October 22, 2022; 12:15PM-1:30PM US ET; Poster #2236
3. Title: Enterobacterales Resistance Patterns for ESBL+ and MDR Urine Isolates Collected and Tested from 295 Outpatient Facilities in 2019
Presenting Author: Mauricio Rodriguez, PharmD, MS-HEOR, BCPS, BCCCP, BCIDP (Spero Therapeutics)
Poster Session: UTIs, October 22, 2022; 12:15PM-1:30PM US ET; Poster #2237
4. Title: The Economic Burden of Adverse Events Requiring Acute Care Services from Outpatient Parenteral Antibiotic Therapy (OPAT) Treatment
Presenting Author: Mauricio Rodriguez, PharmD, MS-HEOR, BCPS, BCCCP, BCIDP (Spero Therapeutics)
Poster Session: Social Determinants of Health, October 21, 2022; 12:15PM-1:30PM US ET; Poster #1416
5. Title: SPR206 Pharmacokinetics (PK) in Plasma, Epithelial Lining Fluid (ELF), and Alveolar Macrophages (AM) in Healthy Adult Subjects
Presenting Author: Keith A. Rodvold, PharmD (University of Illinois Chicago)
Poster Session: PK/PD Studies, October 20, 2022; 12:15PM-1:30PM US ET; Poster #625
6. Title: Activity of SPR206 and Comparator agents against Pseudomonas aeruginosa and Acinetobacter baumannii Causing Infections in the United States Hospitals
Presenting Author: Rodrigo E. Mendes, PhD (JMI Laboratories)
Poster Session: Antimicrobial Novel Agents, October 22, 2022; 12:15PM-1:30PM US ET; Poster #1676
7. Title: In Vitro Activity of SPR206 and Comparator Compounds Against Enterobacterales Isolates Responsible for Infections in United States Hospitals
Presenting Author: Rodrigo E. Mendes, PhD (JMI Laboratories)
Poster Session: Antimicrobial Novel Agents, October 22, 2022; 12:15PM-1:30PM US ET; Poster #1677
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 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.
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, headquartered in Cambridge, Massachusetts, is a multi-asset, clinical-stage biopharmaceutical company focused on identifying, developing, and commercializing novel treatments for serious bacterial infections, including MDR bacterial infections and rare diseases.
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 U.S. Securities and Exchange Commission. The forward-looking statements included in this press release represent Spero’s views as of the date of this press release. Spero anticipates that subsequent events and developments will cause its views to change. However, while Spero may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Spero’s views as of any date subsequent to the date of this press release.
Investor Relations Contact:
Ted Jenkins
Vice President, Investor Relations and Strategic Finance
IR@sperotherapeutics.com
(617) 798-4039
Media Inquiries:
Matt Dick, Health Media Relations
Zeno Group
matt.dick@zenogroup.com
301-509-8532
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