Arch acquires a new CKD platform that has the potential to produce next-generation CKD drugs for the pharmaceutical industry Based on a novel mechanism of action involving IL-32 and directly implicated in CKD, discovered in pre-clinical studies led by Dr. Justin Chun The Company has filed both composition and method of use patents relating to the CKD platform. The Arch CKD program will be led by Dr. Justin Chun, who joins the Company as a Principal Scientist CKD is largely an unmet medical need, currently a ...

Core Insights - Arch Biopartners Inc. has initiated dosing in its Phase II trial for LSALT peptide aimed at preventing cardiac surgery-associated acute kidney injury (CS-AKI) with the first patient successfully dosed at Toronto General Hospital [1][9] - The trial is a multi-center, randomized, double-blind, placebo-controlled study targeting 240 patients, with the primary objective to evaluate the incidence of acute kidney injury within seven days post cardiac surgery [4][12] - The company is expanding its clinical trial sites in Canada and the United States, with St. Michael's Hospital expected to be the next site activated [3][9] Company Overview - Arch Biopartners is focused on developing drugs targeting the dipeptidase-1 (DPEP1) pathway to prevent organ damage caused by inflammation, particularly in the kidneys, lungs, and liver [14][10] - LSALT peptide is the lead drug candidate, which has shown a strong safety profile in previous trials and aims to address the significant unmet medical need for therapies preventing CS-AKI [13][10] Trial Details - The ongoing Phase II trial involves a dosing regimen of 10mg of LSALT peptide administered intravenously twice daily for five days, with subjects randomized to receive either the peptide or a placebo [4][10] - The trial's completion is estimated for August 2026, reflecting the time required for Canadian sites to prepare and obtain necessary approvals [6] Clinical Significance - CS-AKI is a common complication in cardiac surgery, affecting up to 30% of patients undergoing on-pump procedures, leading to serious health risks and increased mortality [12][8] - The LSALT peptide represents a potential first-in-class therapeutic approach to mitigate inflammation injury in this high-risk patient population [13][10]

Core Viewpoint - Arch Biopartners Inc. has received ethics approval for its Phase II trial of LSALT peptide aimed at preventing cardiac surgery-associated acute kidney injury (CS-AKI) [1][2] Group 1: Trial Details - The CS-AKI Phase II trial is an international, multi-center, randomized, double-blind, placebo-controlled study targeting 240 patients [3] - The primary objective is to evaluate the percentage of subjects with acute kidney injury within seven days following on-pump cardiac surgery, based on KDIGO criteria [3][4] Group 2: Recruitment and Locations - Toronto General Hospital is the seventh site activated globally and the second in Canada for patient recruitment [2] - The company plans to reduce recruitment in Turkey and increase it in Canada to enhance the trial's geographic and demographic data [2] Group 3: Background on CS-AKI and LSALT Peptide - CS-AKI is often caused by ischemia-reperfusion injury, leading to kidney cell damage, with no current therapeutic treatments available for this condition [5][6] - LSALT peptide is the lead drug candidate targeting the DPEP1 pathway, showing promise in preventing ischemia-reperfusion injury in pre-clinical models [6][8] Group 4: Incidence and Impact of CS-AKI - The prevalence of CS-AKI can be as high as 30% in patients undergoing on-pump cardiac surgeries, which is associated with increased morbidity and mortality [7]