“ADAPT-PO was a landmark trial that is the first Phase 3 head-to-head comparison of an all-oral versus all-IV treatment regimen in complicated urinary tract infection (cUTI) or acute pyelonephritis,” said
“We are honored to have the results of our global Phase 3 trial published in The
About Spero Therapeutics
Spero Therapeutics is a multi-asset, clinical-stage biopharmaceutical company focused on identifying, developing, and commercializing novel treatments for bacterial infections, including multidrug resistant bacterial infections and rare diseases.
- The NDA for tebipenem pivoxil oral tablets (tebipenem HBr), Spero Therapeutics’ lead product candidate, is currently being reviewed by the FDA; tebipenem HBr is not FDA-approved.
- Tebipenem HBr is an investigational drug in the United States being developed for the treatment of complicated urinary tract infection, including pyelonephritis, caused by certain microorganisms, in adult patients who have limited oral treatment options.
Spero Therapeuticsis also developing SPR720 as a novel candidate oral therapy for the treatment of a rare, orphan pulmonary disease caused by non-tuberculous mycobacterial infections.
Spero Therapeuticsalso has an IV-administered next generation polymyxin product candidate, SPR206, developed from its potentiator platform, which is in development to treat multidrug resistant Gram-negative infections in the hospital setting.
For more information, visit https://sperotherapeutics.com.
Tebipenem HBr Research Support
This project has been funded in part with Federal funds from the
Forward Looking Statements
This press release may contain forward-looking statements. These statements include, but are not limited to, potential approval of tebipenem HBr by the FDA and the timing thereof; Spero’s anticipated commercial launch of tebipenem HBr following FDA approval and the timing thereof; the sufficiency of Spero’s cash resources and Spero’s anticipated expenses; potential payments under Spero’s agreement with BARDA; the ability of the Company to receive payments under the HCR financing facility; future clinical trials for pediatric use of tebipenem HBr; future use of tebipenem HBr for pediatric patients; the potential number of patients who could be treated by tebipenem HBr and market demand for tebipenem HBr generally; the effectiveness of tebipenem HBr and its potential impact on healthcare resource utilizations;; and the availability of additional non-dilutive funding from governmental agencies beyond any initially funded awards . 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 Spero’s NDA for tebipenem HBr, for which Spero is currently engaged in discussions with the FDA, is sufficient for approval of tebipenem HBr, including the resolution of any deficiencies identified in such review; whether any additional information we provide to the FDA during the NDA review process may cause delays or extend the PDUFA goal action date; whether the FDA will require any additional clinical data or place labeling restrictions on the use of tebipenem HBr that would add costs for us, delay approval and/or reduce the commercial prospects of tebipenem HBr; Spero’s readiness for an anticipated launch of tebipenem HBr if approval is obtained; if the NDA for tebipenem HBr is not approved by
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Source: Spero Therapeutics, Inc.