The results of the Phase II trial provided first-ever evidence validating Dipeptidase-1 (DPEP1) as a mediator of organ inflammation and therapeutic target in humans. In addition, LSALT peptide was well tolerated with no safety issues related to the drug.
The Phase II trial was an international, multicenter, randomized, double-blind, placebo-controlled, proof of concept study of LSALT peptide for the prevention of organ inflammation such as acute respiratory distress syndrome (ARDS) and acute kidney injury (AKI) in hospitalised patients infected with SARS-CoV-2. The exploratory, adaptive trial was initiated in the early stages of the global pandemic to identify clinical signals of efficacy for LSALT peptide in the treatment of acute lung and kidney inflammation.
Publication Details
Citation
Somayaji R, Luke DR, Lau A, et al Multicentre, randomised, double-blind, placebo-controlled, proof of concept study of LSALT peptide as prevention of acute respiratory distress syndrome and acute kidney injury in patients infected with SARS-CoV-2 (COVID-19). BMJ Open 2024;14:e076142. doi: 10.1136/bmjopen-2023-076142
Authors
Ranjani Somayaji, David R Luke, Arthur Lau, Rahmet Guner, Ŏ Fehmi Tabak, Mark Hepokoski, Nancy Gardetto, Steven A Conrad, Sunil D Kumar, Kalyan Ghosh, Stephen M Robbins, Donna L Senger, Daisy Sun, Rachel K S Lim, Jonathan Liu, Fatma Eser, Ridvan Karaali, Alain Tremblay, Daniel Muruve
Abstract
Dipeptidase-1 (DPEP1) is a recently discovered leucocyte adhesion receptor for neutrophils and monocytes in the lungs and kidneys and serves as a potential therapeutic target to attenuate inflammation in moderate-to-severe COVID-19. We aimed to evaluate the safety and efficacy of the DPEP-1 inhibitor, LSALT peptide, to prevent specific organ dysfunction in patients hospitalised with COVID-19.
The primary endpoint was the proportion of subjects alive and free of respiratory failure and/or the need for renal replacement therapy (RRT). Numerous secondary and exploratory endpoints were assessed including ventilation-free days, and changes in kidney function or serum biomarkers.
“We report the results of a Phase 2 clinical trial testing the hypothesis that LSALT peptide was safe and could attenuate pulmonary and renal inflammation and injury in patients with moderate-to-severe COVID-19 infection”
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