2022-04-21 | NDAQ:SPRO | Press release
CAMBRIDGE, Mass., April 21, 2022 (GLOBE NEWSWIRE) — Spero Therapeutics, Inc. (Nasdaq: SPRO) today announced two oral presentations and four poster presentations at 32n/a European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) to be held April 23-26, 2022 in Lisbon, Portugal.
The oral presentations will provide scientific information on Spero’s investigational oral antibiotic candidate, tebipenem HBr. There are also four posters that feature additional data related to tebipenem HBr, including Spero’s P0213 poster, 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 United States Food and Drug Administration.
The oral presentations at ECCMID are as follows:
- Title: Plasma pharmacokinetics and intrapulmonary penetration of tebipenem in healthy subjects
Speaker: Keith Rodvold, Pharm.D. (University of Illinois at Chicago)
Date: April 24, 2022
Oral session: (2h) PK/PD and TDM clinical studies to improve the dosage of anti-infectives
- Title: Effect of tebipenem on normal gut microbiota in a healthy adult population
Speaker: Tsegaye Sewunet, Ph.D. (Karolinska Institute, Stockholm, Sweden)
Date: April 25, 2022
Oral session: (2h) Studies of microbial diversity in various contexts
Spero Therapeutics’ ECCMID 2022 Scientific Exchange Submissions are available at Main publications and presentations on the Spero Therapeutics website.
Support for Tebipenem HBr Research
These projects were funded in part by federal funds from the US 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.
Spero Therapeutics is a clinical-stage, multi-asset biopharmaceutical company focused on the identification, development and commercialization of 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 under review by the FDA; tebipenem HBr is not FDA approved.
- Tebipenem HBr is an investigational drug in the United States under development for the treatment of complicated urinary tract infections, including pyelonephritis, caused by certain microorganisms, in adult patients who have limited oral treatment options .
- Spero Therapeutics is also developing SPR720 as a new oral therapy candidate for the treatment of a rare orphan lung disease caused by non-tuberculous mycobacterial infections.
- Spero Therapeutics also has a next-generation, intravenously administered polymyxin product candidate, SPR206, developed from its potentiation platform, which is being developed to treat multidrug-resistant Gram-negative infections in the hospital setting.
For more information, visit https://sperotherapeutics.com.
This press release may contain forward-looking statements. These statements include, but are not limited to, potential FDA approval of tebipenem HBr and timing thereof, and Spero’s anticipated commercial launch of tebipenem HBr after FDA approval and timing. of it. In some instances, forward-looking statements may be identified by words such as “may,” “will,” “should,” “expect,” “plan,” “objective,” “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 these forward-looking statements due to a variety of 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. tebipenem. HBr, including the resolution of any deficiencies identified during this review; whether additional information we provide to the FDA during the NDA review process may cause delays or extend the PDUFA target action date; whether the FDA will require additional clinical data or impose labeling restrictions on the use of tebipenem HBr that would increase costs to us, delay approval, and/or reduce the commercial prospects of tebipenem HBr; Spero’s readiness for an early 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 initial proceeds received under its revenue interest financing agreement; the COVID-19 pandemic; Need for additional funding from Spero; the long, expensive and uncertain process of developing clinical drugs; 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 manage its growth; whether Spero’s cash resources will be sufficient to fund its continued operations during the scheduled periods and/or tests; and other factors discussed in the “Risk Factors” set forth in documents filed by Spero from time to time with the United States Securities and Exchange Commission. The forward-looking statements included in this press release represent the opinions of Spero as of the date of this press release. Spero expects subsequent events and developments to change his view. However, while Spero may choose to update these forward-looking statements at some time in the future, it expressly disclaims any obligation to do so. These forward-looking statements should not be taken to represent the views of Spero as of any date subsequent to the date of this press release.
Contact with Investor Relations:
Vice President, Investor Relations
Jacqueline Pomfret Kirby
Vice President, Corporate Affairs