Spero Therapeutics Hosting Key Opinion Leader Call on Oral Tebipenem HBr for the Treatment of Complicated Urinary Tract Infections
CAMBRIDGE, Mass., Sept. 24, 2020 (GLOBE NEWSWIRE) -- Spero Therapeutics Inc. (Nasdaq: SPRO), a multi-asset clinical-stage biopharmaceutical company focused on identifying, developing and commercializing treatments in high unmet need areas involving multi-drug resistant bacterial infections and rare diseases, today announced it will host a key opinion leader (KOL) call on oral tebipenem HBr for the treatment of complicated urinary tract infections on Wednesday, September 30, 2020 at 11:30 a.m. Eastern Time.
The call will feature a presentation by KOL Keith Kaye, MD, MPH, University of Michigan Medical School, who will discuss the current treatment landscape and unmet medical need in complicated urinary tract infections (cUTI). Dr. Kaye will be available to answer questions during the call.
Spero's management team will also discuss the recently announced positive top-line data from Spero’s ADAPT-PO Phase 3 clinical trial of oral tebipenem HBr for the treatment of cUTI and acute pyelonephritis (AP). The ADAPT-PO trial met its primary endpoint of demonstrating that oral tebipenem HBr is statistically non-inferior to intravenous ertapenem, the most commonly used carbapenem for the treatment of cUTI and AP.
|Wednesday, September 30, 2020 @ 11:30a.m. Eastern Time|
|Webcast:||Click Here for Webcast|
A webcast of the presentation may also be accessed through the Spero Therapeutics’ website (www.sperotherapeutics.com) on the “Events and Presentations” page under the “Investors and Media” tab. A replay of the presentation will be archived on the website for 90 days following the conclusion of the event.
About Dr. Keith Kaye:
Dr. Kaye is a Professor of Medicine in the Division of Infectious Diseases and Department of Medicine at University of Michigan Medical School. He is the Director of Research for the Division of Infectious Diseases.
He has devoted his career to the prevention and effective management of healthcare-associated infections. In addition to serving in a variety of quality improvement and administrative roles in infection prevention, antimicrobial stewardship, and quality and patient safety, he has served on national and international clinical guidelines committees.
In addition to his clinical work, Dr. Kaye’s research interests include the development of antimicrobial resistance, particularly among gram-negative organisms; prevention of healthcare associated infections; management of hospital-acquired infections in the elderly; and innovative approaches to antimicrobial stewardship. He has a long and consistent record of federal funding for research pertaining to management and prevention of multi-drug resistant organisms and healthcare-associated infections, including groundbreaking clinical trials.
Dr. Kaye received his medical degree from the University of Pennsylvania and completed his Internal Medicine residency and Infectious Diseases fellowship at Beth Israel Deaconess Medical Center in Boston, MA. During fellowship, Dr. Kaye earned a Masters in Public Health from the Harvard School of Public Health. Dr. Kaye has authored over 300 peer-reviewed articles and 20 book chapters and has presented original research at national and international conferences. Dr. Kaye is Past President of the Society for Health Epidemiology of America (SHEA). He is a recognized expert in healthcare epidemiology and antimicrobial resistance and has been invited to speak on these topics at venues throughout the world.
About Tebipenem HBr
Tebipenem HBr (tebipenem pivoxil hydrobromide; formerly SPR994) is Spero’s novel investigational 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 complicated urinary tract infections, including acute pyelonephritis. The Company expects that the favorable ADAPT-PO clinical trial results, once finalized, will support completion of a New Drug Application submission to the U.S. Food and Drug Administration (FDA) for tebipenem HBr in the second quarter of 2021. If approved, tebipenem HBr would be the first oral carbapenem antimicrobial to receive marketing approval in the United States. Tebipenem HBr has been granted Qualified Infectious Disease Product (QIDP) and Fast Track designations by the FDA for the treatment of cUTI and AP.
About Spero Therapeutics
Spero Therapeutics, Inc. is a multi-asset, clinical-stage biopharmaceutical company focused on identifying, developing and commercializing novel treatments for multidrug-resistant (MDR) bacterial infections and rare diseases.
Spero’s lead product candidate, tebipenem HBr (tebipenem pivoxil hydrobromide; formerly SPR994), is designed to be the first oral carbapenem antibiotic for use in adults to treat serious bacterial infections, including those caused by MDR Gram-negative infections. In September 2020, Spero announced positive top-line results from its Phase 3 ADAPT-PO clinical trial of tebipenem HBr in complicated urinary tract infection and acute pyelonephritis.
Spero is also advancing SPR720, its novel oral therapy product candidate designed for the treatment of rare, orphan pulmonary disease caused by non-tuberculous mycobacterial (NTM) infections.
Spero also has an IV-administered next generation polymyxin product candidate, SPR206, developed from its potentiator platform that is being developed to treat MDR 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, statements about the initiation, timing and submission to the FDA of a NDA for tebipenem HBr and the potential approval of tebipenem HBr by the FDA; future commercialization, the potential number of patients who could be treated by tebipenem HBr and market demand for tebipenem HBr generally; expected broad access across payer channels for tebipenem HBr; the expected pricing of tebipenem HBr and the anticipated shift from IV to oral administration. 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 Spero’s ability to timely complete related Phase 1 trials for NDA submission, taking into account the possible effects of the COVID-19 pandemic; Spero’s need for additional funding; the lengthy, expensive, and uncertain process of clinical drug development; Spero’s reliance on third parties to manufacture, develop, and commercialize its product candidates, if approved; the ability to develop and commercialize Spero’s product candidates, if approved; the potential impact of the COVID-19 pandemic; Spero’s ability to retain key personnel and to manage its growth; 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.
Spero Investor and Media Contact:
Senior Director, Investor Relations