Core Insights - Arch Biopartners Inc. has received ethics approval from the University Health Network Research Ethics Board for St. Michael's Hospital to participate in the Phase II trial of LSALT peptide aimed at preventing and treating cardiac surgery-associated acute kidney injury (CS-AKI) [1][2] Company Overview - Arch Biopartners Inc. is a therapeutic biotech company focused on developing novel drugs for acute kidney injury (AKI) and chronic kidney diseases (CKD), with a pipeline targeting inflammation- and toxin-related kidney injury [17] Clinical Trial Details - The CS-AKI Phase II trial is an international, multi-center, randomized, double-blind, placebo-controlled study with a recruitment target of 240 patients, where subjects will receive either LSALT peptide (10mg IV twice daily for five days) or placebo [5] - The primary objective is to evaluate the percentage of subjects with acute kidney injury within seven days following on-pump cardiac surgery, as defined by KDIGO criteria [5][6] Current Status of the Trial - St. Michael's Hospital will be the ninth site activated globally and the fourth within a leading Canadian academic hospital network, with operational approvals and training underway before patient enrollment [2][4] - Other sites, including Toronto General Hospital and the University of Calgary, are actively enrolling patients, while Royal Columbian Hospital has received REB approval and is preparing for site initiation [4] Medical Context - CS-AKI is a common complication following cardiac surgery, affecting up to 30% of patients undergoing on-pump procedures, leading to serious complications and increased mortality [11][12] - There are currently no approved therapies for CS-AKI, highlighting a significant unmet medical need that LSALT peptide aims to address [12] Mechanism of Action - LSALT peptide is designed to prevent inflammation injury in the kidneys, lungs, and liver by binding to the dipeptidase-1 (DPEP1) enzyme, which plays a role in triggering organ inflammation [8] - Pre-clinical models have demonstrated LSALT's ability to prevent ischemia-reperfusion injury to the kidneys, supporting its therapeutic potential [8] Previous Research Findings - An earlier Phase II trial for acute lung inflammation showed that patients treated with LSALT peptide had significant reductions in inflammatory biomarkers, validating DPEP1 as a therapeutic target [9]

Core Viewpoint - Arch Biopartners Inc. has received ethics approval for St. Michael's Hospital to participate in a Phase II trial evaluating LSALT peptide for preventing and treating cardiac surgery-associated acute kidney injury (CS-AKI) [1][2]. Company Overview - Arch Biopartners Inc. is a therapeutic biotech company focused on developing novel drugs for acute kidney injury (AKI) and chronic kidney diseases (CKD) [16]. - The company is advancing an integrated program targeting inflammation- and toxin-related kidney injury, with LSALT peptide as its lead drug candidate [16]. Clinical Trial Details - The CS-AKI Phase II trial is an international, multi-center, randomized, double-blind, placebo-controlled study with a recruitment target of 240 patients [5]. - Patients will be randomized to receive either LSALT peptide (10mg IV twice daily for five days) or placebo, with the primary objective being to evaluate the percentage of subjects with acute kidney injury within seven days following on-pump cardiac surgery [5][6]. Research and Development - The trial aims to address a significant unmet medical need, as up to 30% of patients undergoing on-pump cardiac surgery develop CS-AKI, which can lead to serious complications and increased mortality [11]. - LSALT peptide works by binding to the dipeptidase-1 (DPEP1) enzyme, inhibiting its role in triggering organ inflammation, and has shown promise in pre-clinical models for preventing ischemia-reperfusion injury to the kidneys [8][7]. Collaboration and Site Activation - St. Michael's Hospital will be the ninth site activated globally and the fourth within a leading Canadian academic hospital network [2]. - Other active sites include Toronto General Hospital and the University of Calgary, with additional sites being evaluated in Canada and the United States [4].

Core Insights - Arch Biopartners Inc. has received approval from the Fraser Health Research Ethics Board for the Royal Columbian Hospital to participate in the Phase II trial of LSALT peptide aimed at preventing and treating cardiac surgery-associated acute kidney injury [1][2] - The company is actively expanding its clinical trial sites, with Royal Columbian Hospital being the eighth site globally and the fourth in Canada to recruit patients [2][3] - Arch Biopartners has completed the acquisition of Lipdro Therapeutics Inc., which includes a CKD drug candidate platform, in exchange for 250,000 common shares and a royalty on future net sales [4] - The Board of Directors has granted 750,000 stock options to directors and officers, exercisable at $1.70 per share for ten years, as part of their remuneration [5] Company Developments - The ongoing Phase II trial for LSALT peptide is part of a broader initiative to address acute kidney injury, with additional sites being evaluated in Canada and the U.S. [3][9] - The acquisition of Lipdro Therapeutics enhances the company's capabilities in developing treatments for chronic kidney disease, targeting IL-32 [4] - Arch Biopartners is focused on developing novel drugs for both acute and chronic kidney diseases, addressing significant unmet medical needs globally [6]