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 3

Previously disclosed in December 2021 and included in the BMJ Open publication, there were no significant differences in adverse events between LSALT peptide and placebo treated patients. The study population of the Phase II trial did not have enough incidence of ARDS or AKI to detect a conclusion on these two particular clinical outcomes. In a secondary evaluation of patients on ventilation, despite being older by an average of 5 years, subjects in the LSALT peptide group demonstrated 22.8 ventilation-free days compared to 20.9 days in the placebo group in the unadjusted analysis at 28 days. “Ventilation” was defined as a need for high flow oxygen therapy (≥ 6L/min), non-invasive ventilation, mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). In a post-hoc analysis adjusting for age, body mass index (BMI), and PaO2/FiO2 ratio (a measure of lung disease severity), the difference in ventilation-free days was 6.7 days favoring the LSALT peptide group compared to the placebo group.

About Phase II trial for LSALT Peptide targeting CS-AKI

Arch Biopartners is currently sponsoring a Phase II trial for LSALT peptide targeting cardiac surgery-associated acute kidney injury (CS-AKI).

CS-AKI is often caused by ischemia-reperfusion injury (IRI) that reduces blood flow (ischemia) and thus oxygen in the kidney causing kidney cell damage. Once blood flow is restored to normal (reperfusion), inflammation is triggered and injury to kidney cells is exacerbated. In the worst cases of AKI, kidneys fail, leading to kidney dialysis or kidney transplant. At present, there are no therapeutic treatments available to prevent or treat CS-AKI or IRI.

The CS-AKI Phase II trial is an international multi-center, randomized, double-blind, placebo-controlled study of LSALT peptide. The recruitment target for the trial is 240 patients. The primary objective of the trial is to evaluate the percentage of subjects with AKI within seven days following on-pump (heart-lung machine) cardiac surgery, defined by the KDIGO (Kidney Disease: Improving Global Outcomes) criteria.

Details of the Phase II trial, entitled “Phase 2 Global, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of LSALT peptide for the Prevention or Attenuation of Acute Kidney Injury (AKI) in Patients Undergoing On-Pump Cardiac Surgery” can be viewed at clinicaltrials.gov.

Recruitment of patients in the CS-AKI trial has begun in three hospital sites in Turkey with a hospital in Canada (University of Calgary) joining the trial last week. Additional sites are expected to be added in Turkey and Canada in the next few weeks.