Currently, most patients with urinary tract infections (UTIs) require long-term antibiotic treatment, which poses risks of resistance development and alters the patients' microbiota. Therefore, vaccines that raise safe, effective and long-lasting immune responses across populations for UTI prevention constitute a critical medical need. However, developing such vaccination strategies remains challenging because the responses need to be specific to a broad range of UTI-causing bacteria and include both blood and mucosal responses in the urogenital tract.
Spero Therapeutics Inc. has come out swinging after a U.S. FDA rejection for its oral antibiotic, tebipenem Hbr, picking up a potential $600 million licensing deal with pharma giant GSK plc after agreeing on a plan with the regulator to revive the drug.
Dartmouth College spinoff Nanopath Inc. closed a $10 million series A funding round to commercialize a point-of-care biosensing platform with ultrasensitive optical detection. The startup is developing a rapid test that provides genetic information in less than 15 minutes without the need for nucleic amplification. To date, the company has generated preliminary data in two clinical indications focused on women’s health: human papillomavirus genotyping and urinary tract infection characterization.
Spero Therapeutics Inc.’s oral antibiotic, tebipenem Hbr, has been rejected by the U.S. FDA for adults with complicated urinary tract infection, after the regulator said a further trial is needed for approval.
Executives of Spero Therapeutics Inc. evaded analysts’ attempts to clarify “deficiencies” noted by the U.S. FDA in its ongoing review of the company’s NDA seeking approval of oral carbapenem antibiotic tebipenem HBr for complicated urinary tract infections (cUTIs), emphasizing instead that they have three months to work with the regulator ahead of a June 27 PDUFA date assigned to the application.
A new antibiotic combination developed by Venatorx Pharmaceuticals Inc. "may represent a significant improvement over the standard of care" for adults with complicated urinary tract infections (cUTI), said Christopher Burns, the company's co-founder, president and CEO.
If there is one thing that potently illustrates the hope and despair of the COVID-19 pandemic, it is the zigzag of BioWorld’s Infectious Disease Index. Up by nearly 64%, it is towering over both the Nasdaq Biotechnology Index and the Dow Jones Industrial Average, which are up 12.4% and 15.5%, respectively, but it has experienced several downward swings this year as well.
Shares of Iterum Therapeutics plc fell 40% July 26 after disclosing that the FDA issued a complete response letter (CRL) for its NDA for sulopenem etzadroxil/probenecid (oral sulopenem), an anti-infective compound, for urinary tract infections (UTIs). The agency determined the NDA cannot be approved in its present form.
An ongoing FDA review of Iterum Therapeutics plc's NDA for a bilayer tablet containing sulopenem etzadroxil and probenecid for uncomplicated urinary tract infections (uUTI) has uncovered "deficiencies that preclude the continuation" of talks on labeling and postmarketing requirements, the company said. The revelation, less than four weeks before the NDA's July 25 PDUFA date, "throws an on-time approval into serious doubt," making Iterum's receipt of a complete response letter "a reasonably likely scenario," H.C. Wainwright analyst Ed Arce wrote.
Mindup, an Israeli digital health incubator, added Phenofast Ltd. to its portfolio this week, banking on the startup’s ability to resolve a critical, ongoing problem for hospitals and community physicians treating patients with urinary tract infections (UTIs). Phenofast hopes to bring clarity to antimicrobial susceptibility testing (AST) and relief to patients in record time.
