Arch Biopartners Clinical Team Publishes Data from Phase II Trial for LSALT Peptide Targeting Organ Inflammation in Hospitalized Patients Infected with SARS-CoV-2 - Seite 2

CXCL10 plays a role in facilitating leukocyte recruitment to various vascular beds including the lungs and kidneys. The reduction of CXCL10 and the other inflammatory biomarkers during LSALT peptide treatment is consistent with LSALT peptide’s mechanism of action as an inhibitor of DPEP-1 mediated leukocyte recruitment to the lungs and kidneys.

The new data provides more scientific rationale for Arch to advance LSALT peptide to prevent leukocyte recruitment and organ inflammation for other indications, including a larger Phase II trial targeting cardiac surgery-associated AKI, which recently began recruiting patients. More information on the current trial can be found below and at clinicaltrials.gov

Details of the results from the Phase II trial are reported in the peer-reviewed journal BMJ Open. The publication, titled “Multicenter, Randomized, 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)” by Somayaji et. al. can be found at the BMJ Open website.

Quote from Richard Muruve, CEO of Arch Biopartners Inc.:

“When the pandemic started and hospitals were filling up with patients with respiratory distress caused by inflammation, we postponed our plans to do a CS-AKI trial to urgently perform a Phase II trial to treat hospitalized COVID patients and reduce acute organ inflammation. Now that we have published our biomarker and clinical data from the trial, we are more confident today that inhibiting DPEP-1 mediated leukocyte recruitment to the kidneys, lungs and liver is a valid path toward first-ever treatments to prevent acute injury in these organs.”

About the Phase II trial for LSALT Peptide in Pandemic Patients

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 patients infected with SARS-CoV-2. Six clinical sites located in Canada, United States, and Turkey participated in the Phase II trial in 2021.

The composite primary endpoint of the Phase II trial reflected the severe effects often experienced by hospitalized patients in the early months of the pandemic and deemed appropriate for LSALT peptide’s novel mechanism of action in blocking consequential inflammation in the lungs, kidneys, and other organs. The exploratory study was designed to detect a clinical signal of efficacy and was not powered for statistical significance.