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The LTI-01-2001 phase 2a trial of intrapleural LTI-01 in patients with infected, non-draining pleural effusions

Lamb, Carla R.; Akulian, Jason; Musani, Ali; Shojaee, Samira; Chen, Alexander; Kurman, Jonathan; Jani, Pushan; Senitko, Michal; Ahmad, Danish; Wahidi, Momen; Ansari, Sikandar; Abu-Hijleh, Muhanned; Ma, Kevin C.; Puchalski, Jonathan; Yarmus, Lonny; Kheir, Fayez; Maldonado, Fabien; Cheng, George; Alvarado, Christian; Karan, Singh P.; Windsor, Brian; Rahman, Najib M.; Shoemaker, Steven; Idell, Steven. (2026).泭.泭Respiratory Research, 27(1), 332.泭

LTI-01 is an enzyme-based treatment designed to improve drainage of infected fluid around the lungs when standard drainage is unsuccessful. In this phase 2a trial, 40 hospitalized patients received one of three doses of LTI-01 or a placebo directly into the pleural space around the lungs for up to three days. Overall, LTI-01 did not significantly reduce treatment failure compared with placebo, although some analyses suggested potential benefits at the 400,000-unit dose. Imaging also showed reductions in the amount of abnormal fluid or tissue around the lungs, particularly with the 800,000-unit dose. Importantly, no major safety concerns or bleeding events were observed. Because enrollment was limited partly by the COVID-19 pandemic, a larger trial is needed to determine whether LTI-01 is an effective treatment for infected pleural effusions that do not drain adequately.

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