BEIJING – With promising phase II data in hand – and newly designated FDA orphan drug status – Suzhou, China-based Tennor Therapeutics Suzhou Co. Ltd. is gearing up to move into pivotal testing with TNP-2092 to treat prosthetic joint infections. TNP-2092 is a multitargeting drug conjugate designed to exert antibacterial activity by inhibiting three essential targets in bacterial biofilms.
Health care-associated infections (HAI) pose a constant challenge for hospitals and health systems, resulting in increased morbidity and mortality and billions in costs each year. According to the Centers for Disease Control and Prevention, about 1 in 31 patients has at least one HAI at any given time. In 2016, the U.S. Department of Health and Human Services set a 2020 goal of reducing HAIs by 50% below a 2015 baseline. To that end, Biotia Inc. plans to launch an artificial intelligence (AI)-enabled test to detect harmful bugs and antimicrobial resistance (AMR) early in the new year.
Toronto-based Moleculight Inc. has received U.S. FDA 510(k) clearance for its i:X hand-held fluorescence imaging device for use in detecting bacteria in wounds at the point of care. The milestone comes a little over a year after the agency granted de novo clearance for the device in August 2018 and lends additional credence to the device’s benefits in wound evaluation and management. “The granting of our 510(k) clearance by the FDA for the i:X hand-held fluorescence imaging device is very exciting and is a further validation of the growing clinical evidence supporting the utility of our imaging platform,” said Anil Amlani, Moleculight’s CEO.