Latest news with #cUTIs
Globe and Mail
28-05-2025
- Business
- Globe and Mail
Biotech Finds Mid-Week Success After Meeting Primary Endpoint
A biotech company based out of Massachusetts found a tremendous amount of success mid-week after the company announced that the pivotal Phase 3 PIVOT-PO trial evaluating tebipenem HBr, an investigational oral treatment for complicated urinary tract infections (cUTIs), met its primary end point and will stop early for efficacy, according to a recent press release. Traders wasted no time snatching up shares of Spero Therapeutics Inc. (Nasdaq:SPRO), pushing the small cap to close the session up at $2.35/share (+244.57%). This move was a massive breakout from the multi-month downtrend this stock was stuck in since last year. Spero Therapeutics Inc is a clinical-stage biopharmaceutical firm. It focuses on identifying, developing and commercializing novel treatments for MDR (Multi-drug-resistant) bacterial infections and rare diseases. The company's product candidate, tebipenem pivoxil hydrobromide or tebipenem HBr, is designed to be an oral carbapenem-class antibiotic for use in adults to treat MDR Gram-negative infections. It is also developing SPR720, a novel oral antibiotic designed for the treatment of a rare, orphan disease caused by pulmonary non-tuberculous mycobacterial infections, or NTM disease. Besides, it is also focused on SPR206, a next-generation polymyxin investigational product candidate, being developed as an IV-administered medicine to treat MDR Gram-negative infections in the hospital. Copyright © 2025 All rights reserved. Republication or redistribution of content is expressly prohibited without the prior written consent of shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon. View more of this article on About Media, Inc.: Founded in 1999, is one of North America's leading platforms for micro-cap insights. Catering to both Canadian and U.S. markets, we provide a wealth of resources and expert content designed for everyone—from beginner investors to seasoned traders. is rapidly gaining recognition as a leading authority in the micro-cap space, with our insightful content prominently featured across numerous top-tier financial platforms, reaching a broad audience of investors and industry professionals. Want to showcase your company's story to a powerful network of investors? We can help you elevate your message and make a lasting impact. Contact us today. Contact: Media, Inc.
Medscape
28-05-2025
- Business
- Medscape
GSK, Spero Stop UTI Drug Trial After Early Success
(Reuters) -Spero Therapeutics and partner GSK are stopping a late-stage trial of an experimental oral drug for complicated urinary tract infections early as the study met its main goal, the companies said on Wednesday. Shares of Spero more than tripled to $2.24 in premarket trading. The decision comes after a recommendation from an independent committee that completed an interim analysis of data from 1,690 patients enrolled in the trial. The companies were studying the oral drug, tebipenem HBr, as a treatment for complicated urinary tract infections (cUTIs), including a type of kidney infection called pyelonephritis. An estimated 2.9 million cases of cUTIs are treated annually in the U.S. alone. The current standard of care includes antibiotics called carbapenem, but those are only available for intravenous administration. In the trial, the drug showed it was at least as good as an intravenous imipenem-cilastatin, a type of antibiotic, in hospitalized adult patients. If approved, the drug could be the first oral carbapenem antibiotic for patients with cUTIs. The review by the committee did not identify any new safety concerns beyond what had been reported in other studies, with diarrhea and headache as the two most reported side effects. The companies had entered into a licensing agreement for the development of tebipenem HBr in 2022. The U.S. FDA had previously declined to approve the drug saying a late-stage study testing it was insufficient and an additional study would be required. The British drugmaker plans to work with U.S. regulatory authorities to include the data as part of a filing in the second half of the year. Full results will be submitted for presentation at an upcoming scientific congress and for publication in a peer-reviewed journal, the companies said. (Reporting by Sriparna Roy and Yadarisa Shabong in Bengaluru; Editing by Devika Syamnath)
