Arch Biopartners Inc. has received ethics committee approval in Turkey to proceed with a Phase II clinical trial of LSALT peptide for the prevention and treatment of cardiac surgery-associated acute kidney injury (CS-AKI). This trial aims to evaluate the efficacy of LSALT peptide, the company's lead drug candidate, in mitigating inflammation-related injuries in the kidneys, lungs, and liver.
Regulatory Pathway and Trial Activation
The ethics approval from the Kocaeli University Clinical Research Ethics Committee is a crucial step forward. According to Arch Biopartners, the approval will be followed by a regulatory review by the Turkish Ministry of Health (MoH), expected to conclude by mid-January. Upon MoH approval, clinical sites in Turkey will be activated, with patient enrollment slated to begin in February.
Richard Muruve, CEO of Arch Biopartners Inc., stated, "We look forward to a positive decision from the MoH, which will permit enrollment of Turkish cardiac surgery patients into the trial. At the same time, we continue to progress on a day-to-day basis to prepare Canadian sites for the trial while waiting for a response from Health Canada on our recent Clinical Trial Application."
CS-AKI and LSALT Peptide: Addressing an Unmet Need
CS-AKI is a frequent complication following coronary artery bypass grafting (CABG) and other cardiac surgeries, particularly those involving on-pump procedures. The incidence of CS-AKI can reach up to 30%, significantly increasing morbidity and mortality. Currently, there are no specific therapeutic treatments available to prevent or treat CS-AKI or ischemia-reperfusion injury (IRI), which often leads to kidney failure, dialysis, or transplant.
LSALT peptide targets the dipeptidase-1 (DPEP-1) pathway, which has demonstrated the ability to prevent IRI to the kidneys in preclinical models. This mechanism provides the scientific basis for Arch Biopartners' investigation of LSALT peptide in the CS-AKI trial.
Trial Design and Scope
The Phase II trial, officially titled "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," is detailed on clinicaltrials.gov. The study is designed to rigorously assess the safety and efficacy of LSALT peptide in a controlled clinical setting.
Financial Support
Arch Biopartners has received advisory services and funding from the National Research Council of Canada Industrial Research Assistance Program (NRC-IRAP), which will substantially offset the costs associated with the CS-AKI Phase II trial. This financial support underscores the potential significance of LSALT peptide in addressing a critical unmet medical need.
About Arch Biopartners
Arch Biopartners Inc. is a late-stage clinical trial company focused on preventing inflammation and acute organ injury. The Company is developing new drug candidates that inhibit inflammation in the lungs, kidneys, and liver via the dipeptidase-1 (DPEP-1) pathway and are relevant for common injuries and diseases where organ inflammation is an unmet problem.
