Arch Biopartners Inc., a clinical-stage company, has announced the approval from the Kocaeli University Clinical Research Ethics Committee in Turkey to move forward with a Phase II trial for its LSALT peptide. This trial focuses on the prevention and treatment of Cardiac Surgery-Associated Acute Kidney Injury (CS-AKI), a condition that currently lacks effective therapeutic treatments.
LSALT peptide is Arch Biopartners' leading drug candidate, designed to prevent and treat inflammation injury in vital organs such as the kidneys, lungs, and liver. The peptide targets the dipeptidase-1 (DPEP-1) pathway, which has shown promise in preventing ischemia-reperfusion injury (IRI) to the kidneys in pre-clinical models.
The ethics committee's approval is a significant step forward, pending a final regulatory review by the Turkish Ministry of Health (MoH), anticipated to be completed by mid-January. Following MoH approval, clinical sites in Turkey will be activated, and patient enrollment is expected to commence in February.
Richard Muruve, CEO of Arch Biopartners Inc., expressed optimism about the trial's progression, stating, "We look forward to a positive decision from the MoH, which will permit enrollment of Turkish cardiac surgery patients into the trial." He also mentioned ongoing preparations for Canadian sites, awaiting a response from Health Canada on the company's recent Clinical Trial Application.
CS-AKI is a severe complication following cardiac surgeries, such as coronary artery bypass grafting (CABG), with a prevalence of up to 30%. It is independently associated with increased morbidity and mortality. The condition is often caused by ischemia-reperfusion injury (IRI), leading to reduced blood flow and oxygen to the kidneys, exacerbating kidney cell damage upon reperfusion.
This Phase II trial, 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," aims to address the unmet need for effective treatments against CS-AKI and IRI.
Arch Biopartners' initiative is supported by advisory services and a funding contribution from the National Research Council of Canada Industrial Research Assistance Program (NRC-IRAP), announced in March 2023, which will significantly offset the trial's costs.
For more detailed information on the trial, interested parties can visit clinicaltrials.gov.