Turkish Ministry of Health Approves Phase II Trial for Arch Biopartners' LSALT Peptide in Cardiac Surgery-Related AKI

Arch Biopartners, a clinical-stage company, has been granted authorization by Turkey's Ministry of Health to initiate a Phase II clinical trial for their flagship drug candidate, LSALT peptide. This trial is aimed at preventing and treating acute kidney injury (AKI) that can occur following cardiac surgery. The LSALT peptide is designed to mitigate inflammation in vital organs such as the kidneys, lungs, and liver.
The company is now preparing to establish clinical trial sites within Turkey, with patient recruitment scheduled to commence in February 2024. Richard Muruve, Arch Biopartners' CEO, expressed optimism about the trial's progression and is concurrently awaiting approval from Health Canada for similar trials in Canada.
Acute kidney injury is a prevalent complication post-cardiac surgery, with an incidence rate of up to 30%, and is linked to increased morbidity and mortality. The LSALT peptide works by targeting the dipeptidase-1 (DPEP-1) pathway, which has demonstrated the potential to prevent ischemia-reperfusion injury (IRI) to the kidneys in pre-clinical studies. This provides a scientific basis for its use in the Phase II trial.
The Phase II trial is a global, multicenter, randomized, double-blind, placebo-controlled study that will evaluate the efficacy of LSALT peptide in preventing or reducing the severity of AKI in patients undergoing on-pump cardiac surgery.
The National Research Council of Canada Industrial Research Assistance Program (NRC-IRAP) has offered advisory services and financial support, which is expected to significantly reduce the costs associated with the Phase II trial. Arch Biopartners is dedicated to developing new drug candidates that address inflammation and acute organ injury through the DPEP-1 pathway, targeting conditions where organ inflammation poses significant challenges.