Arch Biopartners Announces University of Calgary Ethics Approval to Proceed With Phase 2 Trial for LSALT Peptide

Arch Biopartners Inc. recently announced the University of Calgary’s Conjoint Health Research Ethics Board (CHREB) has approved the Phase 2 trial for LSALT peptide targeting the prevention and treatment of cardiac surgery-associated acute kidney injury (CS-AKI).

The clinical team at the University of Calgary Cumming School of Medicine is now able to work with Arch to complete preparation and training to enable the start of patient recruitment in Calgary. This work will be completed while waiting for the expected final approval from Alberta Health Services.

The trial continues to have patient recruitment at five clinical sites in Turkey. Since the trial began dosing patients in March, there have been enhancements to the design of the study protocol to help improve the execution of the trial. These changes have since been approved by Health Canada and are pending approval by the Turkish Ministry of Health.

“We are happy to see the ethics approval from the CHREB and we are looking forward to the start of patient recruitment in our CS-AKI Phase 2 trial at the University of Calgary Hospital. We are satisfied with the progress made to date in the trial at our five actively recruiting hospital sites in Turkey. The start of dosing in Canada, first in Calgary and followed by our two sites in Toronto, will be a big boost to the trial overall,” said Richard Muruve, CEO Arch Biopartners.

The CS-AKI Phase 2 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 (AKI) within seven days following on-pump (heart-lung machine) cardiac surgery, defined by the KDIGO (Kidney Disease: Improving Global Outcomes) criteria.

Details of the Phase 2 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 can be viewed at clinicaltrials.gov.

CS-AKI is often caused by ischemia-reperfusion injury (IRI) that reduces blood flow (ischemia) and thus oxygen in the kidney, causing kidney cell damage. Once blood flow is restored to normal (reperfusion), inflammation is triggered and injury to kidney cells is exacerbated. 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 AKI, the kidneys fail, requiring kidney dialysis or kidney transplant for survival.

LSALT peptide is the company’s 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 IRI to the kidneys in pre-clinical models (video), providing the scientific rationale for Arch to use LSALT peptide in this CS-AKI trial. Details of their findings were published in the journal, Science Advances, titled Dipeptidase-1 governs renal inflammation during ischemia reperfusion injury by Lau et. al. and can be found along with the latest peer-reviewed publications about DPEP1 and LSALT peptide at the Company’s website.

Acute kidney injury is a known common complication in patients after coronary artery bypass grafting (CABG) and other cardiac surgeries, including on-pump surgeries which increase the risk of AKI. The reported prevalence of CS-AKI is up to 30% and is independently associated with an increase in morbidity and mortality.

Arch Biopartners Inc. is a late-stage clinical trial company focused on preventing inflammation and acute organ injury. The Company is developing a platform of new drugs to prevent inflammation in the kidneys, liver and lungs via the dipeptidase-1 (DPEP1) pathway and are relevant for many common injuries and diseases where organ inflammation is an unmet problem. For more information, visit www.archbiopartners.com/our-science.