Phase Ib Clinical Trial
LTI-01 has been assessed in a first-in-human, open-label, dose escalation safety study (Beckert et al., 2019) in patients presenting with pneumonia and CPE/empyema. LTI-01 was administered once per day for up to three consecutive days.
At the doses tested, LTI-01 was well tolerated with no safety signals of concern. No local or systemic bleeding was observed. All adverse events observed were considered unrelated to study drug. Additionally, LTI-01 showed preliminary signs of efficacy, with reductions in pleural opacity and declines in pleural infection indicators. These results suggest that the compound effectively clears scar tissue with once-a-day dosing for 3 days and promotes fluid drainage around the lungs without any significant bleeding and other side effects.
LTI-01 is currently in a Phase 2, randomized, placebo-controlled, double-blind, dose-ranging study evaluating LTI-01 in patients with infected, non-draining loculated pleural effusions.
LTI-01 has received Orphan Drug Designation in the US and EU and Fast Track Designation in the US.