Arch Biopartners has dosed the first patient in Canada in its Phase II clinical trial of LSALT peptide (Metablok) for preventing and treating cardiac surgery-associated acute kidney injury (CS-AKI). The University of Calgary Cumming School of Medicine’s clinical team has initiated screening and dosed the first subject in Calgary, Alberta. This multicenter, international, randomised, double-blind, placebo-controlled trial will evaluate the drug candidate versus placebo.
The trial aims to recruit 240 participants, with 120 patients each randomised into the LSALT peptide or placebo arms. Participants will be monitored for safety and efficacy until day 28, with day one regarded as the day of subject randomisation and the study drug administration at least one hour before the induction of anaesthesia.
The trial’s primary goal is to assess the percentage of patients with acute kidney injury within seven days of on-pump cardiac surgery, in line with the Kidney Disease: Improving Global Outcomes (KDIGO) criteria. An independent Data and Safety Monitoring Board (DSMB) will evaluate patient data, focusing primarily on safety assessments.
LSALT peptide works by targeting the dipeptidase-1 (DPEP1) pathway. Its potential in preventing ischaemia-reperfusion injury to the kidneys was demonstrated in pre-clinical models.
Arch Biopartners CEO Richard Muruve said, “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 CS-AKI. 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.”
In addition to Canada, Arch Biopartners has also begun recruiting and dosing subjects in Turkey for the Phase II trial of LSALT peptide.
