Arch Biopartners Doses First Patient in Canada for Phase II Trial of LSALT Peptide

Arch Biopartners Doses First Patient in Canada for Phase II Trial of LSALT Peptide

By, Admin 14 November 2024

Arch Biopartners doses first patient in Canada for phase II trial of LSALT peptide to treat cardiac surgery associated acute kidney injury

Overview

Arch Biopartners Inc, a late-stage clinical trial company focused on preventing inflammation and acute organ injury, has announced that patient recruitment and dosing have begun in Canada for the phase II trial for LSALT peptide targeting the prevention and treatment of cardiac surgery-associated acute kidney injury (CS-AKI).

Patient Screening Initiation

The clinical team at the University of Calgary Cumming School of Medicine has started screening patients for the trial and has completed dosing of the first patient recruited into the study in Calgary, Alberta.

The Ethics and Hospital Approvals

The University Health Network and Unity Health Toronto are also in the final stage of obtaining ethics and hospital approvals to start patient recruitment into the trial at Toronto General Hospital and St. Michael’s Hospital, respectively.

Words from the CEO: Arch Biopartners

  • “We are happy to see the team at the University of Calgary Hospital recruit and dose the first patient in Canada for our phase II study targeting cardiac surgery-associated acute kidney injury. Our five clinical sites in Turkey have made good recruitment progress and have done a great job executing the trial to date.” 
  • “The start of recruitment in Calgary, followed by the activation into the study of the two Toronto hospitals, will significantly boost the momentum of the trial”, said Richard Muruve, CEO, Arch Biopartners.

The Phase II Trial

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

About the CS-AKI

  • Cardiac surgery-associated acute kidney injury often results from ischemia-reperfusion injury, which restricts blood flow and oxygen to the kidney (ischemia), leading to kidney cell damage. 
  • When blood flow is restored (reperfusion), inflammation is triggered, exacerbating injury to the kidney. 
  • There is no therapeutic treatment available in the market today that prevents acute kidney injury of the type commonly experienced by on-pump cardiac surgery patients. 
  • In the worst cases of acute kidney injury, the kidneys fail, requiring kidney dialysis or kidney transplant for survival.

About the LSALT Peptide

  • LSALT peptide is Arch Biopartners’ lead drug candidate for preventing and treating inflammation injury in the kidneys, lungs and liver. 
  • The drug targets the dipeptidase-1 (DPEP1) pathway and has been shown by Arch scientists and their collaborators to prevent ischemia-reperfusion injury to the kidneys in pre-clinical models, providing the scientific rationale for Arch Biopartners’ to use LSALT peptide in this CS-AKI trial.

Acute Kidney Injury

  • Acute kidney injury is a common complication, with an increased risk in patients undergoing coronary artery bypass grafting and other on-pump cardiac surgeries. 
  • The reported prevalence of CS-AKI is up to 30 per cent, and it is independently associated with higher morbidity and mortality rates.