CAMBRIDGE, Mass., April 21, 2022 (GLOBE NEWSWIRE) -- Spero Therapeutics, Inc. (Nasdaq: SPRO) today announced two oral presentations and four poster presentations at the 32nd European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) being held April 23-26, 2022, in Lisbon, Portugal.
The oral presentations will provide scientific information regarding Spero’s oral antibiotic investigational candidate tebipenem HBr. There are also four posters that present additional data related to tebipenem HBr, including Spero's poster P0213, which was selected by the ECCMID Program Committee as one of the top-rated posters for this year's Congress. Tebipenem HBr is an investigational drug and has not been approved by any regulatory authority including the U.S. Food and Drug Administration.
The oral presentations at ECCMID are as follows:
- Title: Plasma pharmacokinetics and intrapulmonary penetration of tebipenem in healthy subjects
Presenting Author: Keith Rodvold, Pharm.D. (University of Illinois Chicago)
Date: April 24, 2022
Oral Session: (2hr) Clinical PK/PD studies and TDM to improve dosing of anti-infectives - Title: Effect of tebipenem on the normal gut microbiota of healthy adult population
Presenting Author: Tsegaye Sewunet, Ph.D. (Karolinska Institute, Stockholm, Sweden)
Date: April 25, 2022
Oral Session: (2hr) Microbial diversity studies across diverse settings
Spero Therapeutics’ ECCMID 2022 scientific exchange submissions can be found at Key Publications and Presentations on the Spero Therapeutics corporate website.
Tebipenem HBr Research Support
These projects have been funded in part with federal funds from the U.S. Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under contract number HHSO100201800015C.
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.
- A New Drug Application for tebipenem pivoxil hydrobromide 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 Therapeutics is 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 Therapeutics also 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.
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 and Spero’s anticipated commercial launch of tebipenem HBr following FDA approval and the timing thereof. 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 December 31, 2022, Spero’s obligation to repay $50 million in upfront proceeds received under its revenue interest financing agreement; the COVID-19 pandemic; Spero’s need for additional funding; the lengthy, expensive, and uncertain process of clinical drug development; 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 and to manage its growth; 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
Tjenkins@sperotherapeutics.com
(617) 798-4039
Media Contact:
Jacqueline Pomfret Kirby
Vice President, Corporate Affairs
Jkirby@sperotherapeutics.com
(617) 798-4074
