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]

Core Insights - Arch Biopartners Inc. has acquired a pre-clinical platform focused on developing new drugs for chronic kidney disease (CKD), specifically targeting interleukin-32 (IL-32) [1][2][3] - The acquisition enhances Arch's kidney drug development pipeline and positions the company for potential new partnerships [2][4] - CKD affects over 800 million people globally, with diabetes being a leading cause, responsible for 30% to 40% of CKD cases [5][6] Company Developments - The CKD program was obtained through the acquisition of Lipdro Therapeutics Inc., involving the issuance of 250,000 common shares at a deemed price of $1.85 per share and a future royalty on net sales [2][3] - Dr. Justin Chun, founder of Lipdro, will join Arch as a Principal Scientist to lead the CKD program [2][4] - The new therapeutic platform is based on a mechanistic understanding of disease pathways and aims to provide novel treatment options for diabetic CKD [4][5] Scientific Insights - IL-32 is identified as a non-classical cytokine involved in inflammation and immune responses, directly implicated in the pathogenesis of diabetic CKD [3][5] - The therapeutic approach developed by Arch and its collaborators is expected to target the underlying mechanisms of inflammation and fibrosis in CKD [5][6] - The new CKD platform represents a significant addition to Arch's kidney drug asset portfolio, focusing on on-target treatment options [7][10] Market Context - The CKD market represents a significant unmet medical need, with approximately 35 to 38 million affected individuals in the U.S. alone [5][6] - Current renal therapies often rely on off-target actions, highlighting the potential for Arch's on-target CKD platform to differentiate itself in the pharmaceutical industry [6][7] - Arch's integrated pipeline includes other programs targeting acute kidney injury, further enhancing its position in the kidney care market [10][11]

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]