Arch Biopartners Doses First Patient in Phase II Trial for Cardiac Surgery-Associated Acute Kidney Injury
Key Insights
Arch Biopartners (search) has dosed the first patient in Canada for its Phase II trial evaluating LSALT peptide for preventing cardiac surgery-associated acute kidney injury (search) (CS-AKI).
The multi-center, randomized, double-blind, placebo-controlled study aims to enroll 240 patients to assess LSALT peptide's efficacy in reducing AKI incidence within seven days post-surgery.
LSALT peptide targets the DPEP1 (search) pathway to mitigate inflammation-related kidney damage, addressing a critical unmet need as there are currently no approved treatments for CS-AKI.
Arch Biopartners (search) Inc. has announced the dosing of the first patient in Canada for its Phase II clinical trial evaluating LSALT peptide for the prevention and treatment of cardiac surgery-associated acute kidney injury (search) (CS-AKI). The trial, which is already underway at five clinical sites in Turkey, is expanding to include sites at the University of Calgary Cumming School of Medicine, University Health Network, and Unity Health Toronto.
Trial Design and Objectives
The Phase II trial is designed as an international, multi-center, randomized, double-blind, placebo-controlled study. It aims to enroll 240 patients undergoing on-pump cardiac surgery. The primary objective is to evaluate the percentage of subjects who develop acute kidney injury (search) (AKI) within seven days following surgery, based on the Kidney Disease: Improving Global Outcomes (KDIGO) criteria. The trial is listed on clinicaltrials.gov.
LSALT Peptide and Mechanism of Action
LSALT peptide is Arch Biopartners (search)' lead drug candidate, targeting the dipeptidase-1 (DPEP1 (search)) pathway to prevent and treat inflammation-related injuries in the kidneys, lungs, and liver. CS-AKI often results from ischemia-reperfusion injury (IRI), where restricted blood flow during surgery leads to kidney cell damage, followed by inflammation upon blood flow restoration. Pre-clinical models have demonstrated LSALT peptide's ability to prevent IRI to the kidneys, as published in Science Advances by Lau et al.
The Need for New Therapies in CS-AKI
Richard Muruve, CEO of Arch Biopartners (search), stated, "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... 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."
Acute kidney injury (search) (AKI) is a common complication in patients undergoing coronary artery bypass grafting (CABG) and other on-pump cardiac surgeries. The reported prevalence of CS-AKI is up to 30%, and it is independently associated with higher morbidity and mortality rates. Currently, there is no therapeutic treatment available to prevent AKI in these patients, highlighting a significant unmet medical need. In severe cases of AKI, kidney failure may necessitate dialysis or transplant for survival.
Arch Biopartners' Focus
Arch Biopartners (search) 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 targeting the DPEP1 (search) pathway to prevent inflammation in the kidneys, liver, and lungs, addressing common injuries and diseases where organ inflammation remains an unmet need.