Spero Therapeutics Announces Presentations on Tebipenem Hbr at IDWeek
Rhea-AI Summary
Spero Therapeutics (Nasdaq: SPRO) announced presentations on oral tebipenem Hbr at IDWeek, Oct 19–22, 2025 in Atlanta.
Company and partner GSK will present late-breaking Phase 3 PIVOT-PO results for tebipenem Hbr in complicated urinary tract infection (cUTI), including pyelonephritis. An oral presentation by David K. Hong is scheduled for Oct 20, 2025, 1:45–3:00 PM ET (Session: Late Breaking Trial Results). Two posters on tebipenem antibacterial activity vs Enterobacterales will be shown on Oct 21, 2025, 12:15–1:30 PM in Poster Hall B4–B5.
Positive
- Phase 3 PIVOT-PO trial reported successful results
- Late-breaking oral presentation on Oct 20, 2025 increases visibility
- Two scientific posters scheduled on Oct 21, 2025 detailing antibacterial activity
Negative
- None.
Insights
Phase 3 PIVOT-PO reports success; topline clinical and safety data presented at IDWeek.
The drug is tebipenem HBr, an investigational oral carbapenem studied for complicated urinary tract infection including pyelonephritis in the Phase 3 PIVOT-PO trial. The company will present efficacy and safety results in a late-breaking oral session on
Key dependencies and risks include whether the disclosed Phase 3 data include complete primary endpoint outcomes and safety details; these facts determine regulatory relevance. Watch the
Successful Phase 3 data for an oral carbapenem could shift treatment options if results hold up in detail.
Spero presents PIVOT-PO Phase 3 efficacy and safety results at IDWeek and lists collaborative work with GSK; the program targets cUTI and pyelonephritis, a clinical indication with clear diagnostic endpoints. The material presented includes an oral late-breaking talk on
Critical items to watch are the oral presentation content on
Late breaking session to feature results from the successful PIVOT-PO Phase 3 trial evaluating tebipenem Hbr in complicated urinary tract infection (cUTI)
CAMBRIDGE, Mass., Oct. 14, 2025 (GLOBE NEWSWIRE) -- Spero Therapeutics, Inc. (Nasdaq: SPRO), a clinical-stage biopharmaceutical company focused on identifying and developing novel treatments for rare diseases and multi-drug resistant (MDR) bacterial infections, today announces presentations on tebipenem Hbr at the upcoming IDWeek annual meeting to take place Oct 19 – 22, 2025 in Atlanta, GA. Tebipenem Hbr is an investigational oral carbapenem being developed for the treatment of complicated urinary tract infection (cUTI), including pyelonephritis. The presentations are being made in collaboration with Spero’s development partner, GSK.
| Oral Presentation | |||
| Title: | Oral Tebipenem Pivoxil Hydrobromide versus Intravenous Imipenem-Cilastatin in Patients with Complicated Urinary Tract Infections or Acute Pyelonephritis: Efficacy and Safety Results from the Phase 3 PIVOT-PO study | ||
| Presenter: | David K. Hong, Senior Vice President, Clinical Development at Spero | ||
| Session Title: | Late Breaking Trial Results for Viral and Bacterial Infections | ||
| Date/ Time: | Monday October 20, 2025, 1:45 PM - 3:00 PM Eastern Time | ||
| Location: | B401-B402 | ||
| Posters: | |||
| Titles: | i. In Vitro Antibacterial Spectrum and Activity of Tebipenem Against Enterobacterales Clinical Isolates Causing Urinary Tract and Bloodstream Infections in the United States and United Kingdom in 2023-2024 | ||
| ii. Activity of Tebipenem Against Enterobacterales, Including Molecularly Characterized Clinical Isolates Causing Urinary Tract and Bloodstream Infections from the United States in 2023 | |||
| Time: | Tuesday 21 October, 12:15 to 1:30 pm | ||
| Location: | Poster Hall B4 to B5 | ||
About tebipenem HBr
Tebipenem HBr is an investigational oral carbapenem antibiotic being developed for the treatment of cUTI, including pyelonephritis, to help patients potentially reduce the duration of in-patient therapy. Spero granted GSK an exclusive license to commercialize tebipenem HBr in all territories, except certain Asian territories where Meiji holds development and commercialization rights. In May 2025, Spero and its development partner GSK announced that the Phase 3 PIVOT-PO trial met the primary endpoint of non-inferiority of tebipenem HBr compared to intravenous imipenem-cilastatin in hospitalized adult patients with cUTI, including pyelonephritis, on overall response (composite of clinical cure plus microbiological eradication) at the test-of-cure visit. Tebipenem HBr has received Qualified Infectious Disease Product (QIDP) and Fast Track designations from the FDA. GSK plans to work with U.S. regulatory authorities to include these data as part of a filing in 4Q 2025.
Government Agency Research Support
The views expressed in this press release are those of the authors and may not reflect the official policy or position of the Department of the Army, Department of Defense, or the U.S. Government.
Tebipenem HBr Research Support
Select tebipenem HBr studies have been funded in part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; and Biomedical Advanced Research and Development Authority, under contract number HHSO100201800015C.
About Spero Therapeutics
Spero Therapeutics, headquartered in Cambridge, Massachusetts, is a clinical-stage biopharmaceutical company focused on identifying and developing novel treatments for rare diseases and MDR bacterial infections with high unmet need. For more information, visit www.sperotherapeutics.com.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements regarding the timing, progress and results of Spero's Phase 3 PIVOT-PO trial; the timing of a planned FDA filing in 2H 2025 for tebipenem HBr; the potential of tebipenem HBr to be the first oral carbapenem antibiotic for US patients with cUTI, including pyelonephritis, and to set a new standard of care; the potential receipt of milestone payments under Spero’s license and collaboration agreements; Spero’s anticipated cash runway; and the potential benefits of any of Spero’s current or future product candidates in treating patients. In some cases, forward-looking statements may be identified by terms such as "may," "will," "should," "expect," "plan," "aim," "anticipate," "could," "intent," "target," "project," "contemplate," "believe," "estimate," "predict," "potential" or "continue," the negative of these terms or other similar expressions. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of important risks, uncertainties and other factors that may cause actual results to differ materially from those indicated by such forward looking statements, including whether tebipenem HBr will advance through the clinical development process, 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; 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, including, in the case of tebipenem HBr, Spero’s reliance on GSK pursuant to the exclusive GSK License Agreement to develop tebipenem HBr and GSK’s right thereunder to determine, in its sole discretion, whether to continue the PIVOT-PO trial or otherwise further develop tebipenem HBr; Spero's need for additional funding; the ability to commercialize Spero's product candidates, if approved; Spero's ability to retain key personnel; Spero's leadership transitions; 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 SEC. The forward-looking statements included in this press release represent Spero's views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. Except as required by law, Spero explicitly disclaims any obligation to update any forward-looking statements.
Investor Relations Contact:
Shai Biran, PhD
Spero Therapeutics
IR@Sperotherapeutics.com
Media Inquiries:
media@sperotherapeutics.com
FAQ
What will Spero present about tebipenem Hbr at IDWeek 2025 (SPRO)?
When and where is the SPRO oral presentation on tebipenem at IDWeek 2025?
Who is presenting Spero's PIVOT-PO results at IDWeek 2025 (SPRO)?
What do the tebipenem posters at IDWeek 2025 cover for SPRO?
Is tebipenem Hbr being developed for complicated urinary tract infections (cUTI)?
