Arch Biopartners Stock Price, News & Analysis

Arch Biopartners Inc. (ACHFF) is a therapeutic biotech company focused on developing novel drugs for acute and chronic kidney diseases and for organ damage caused by inflammation and toxins. The company’s work centers on the dipeptidase-1 (DPEP1) pathway, which is prevalent in the kidneys, lungs, and liver, and on mechanism-based approaches to kidney disease that address specific biological drivers of injury.

Arch Biopartners’ shares trade on the TSX Venture Exchange under the symbol ARCH and on the OTCQB under the symbol ACHFF. According to company disclosures, it operates as a late-stage clinical trial company, advancing multiple drug candidates in Phase II clinical studies targeting acute kidney injury (AKI) and building a pre-clinical platform for chronic kidney disease (CKD).

Kidney-Focused Drug Development Pipeline

Arch Biopartners describes its business as developing a platform of new drugs to prevent inflammation injury and acute organ damage via the DPEP1 pathway and related mechanisms. Its programs target serious unmet medical needs in global kidney care, including AKI caused by inflammation, AKI caused by drug toxins, and chronic kidney disease, particularly diabetic CKD.

The company highlights three key kidney-focused assets:

• LSALT peptide – A novel peptide drug candidate and first-in-class inhibitor of the DPEP1 inflammation pathway. LSALT peptide is the company’s lead drug candidate and is in a Phase II, international, multicenter, randomized, double-blind, placebo-controlled trial targeting cardiac surgery-associated acute kidney injury (CS-AKI). Arch reports that LSALT peptide is designed to prevent and treat inflammation injury in the kidneys, lungs, and liver by targeting DPEP1, which has been identified as a major leukocyte adhesion receptor on lung, liver, and kidney endothelium.
• Cilastatin – A repurposed enzymatic DPEP1 inhibitor that Arch is developing as a new treatment for drug toxin-related acute kidney injury. Cilastatin was originally developed and approved as part of a fixed combination with the antibiotic imipenem to treat bacterial infections. Arch states that there is no commercial history of cilastatin as a stand-alone drug product and that it owns and has exclusively licensed method-of-use patents to repurpose cilastatin as a treatment for AKI in several jurisdictions. The company emphasizes cilastatin’s off-target effects that block toxin uptake into kidney tissue, making it particularly suited for toxin-related AKI.
• IL-32 CKD platform – A pre-clinical chronic kidney disease program targeting interleukin-32 (IL-32), an intracellular, unconventional cytokine implicated in the pathogenesis of diabetic CKD. Arch reports that it acquired this CKD platform through the purchase of Lipdro Therapeutics Inc., a private Alberta-based company, in exchange for Arch common shares and a royalty on future net sales, subject to TSX Venture Exchange approval. The platform includes composition and method-of-use patents for new drug candidates targeting IL-32, developed in collaboration with the National Research Council of Canada (NRC) and Arch scientists, and exclusively licensed to Arch by the NRC.

Clinical Trials and Indications

Arch Biopartners positions itself as a late-stage clinical trial company. Its disclosures describe multiple ongoing or planned Phase II studies:

• CS-AKI Phase II trial (LSALT peptide) – An international, multicenter, randomized, double-blind, placebo-controlled study evaluating LSALT peptide for the prevention or attenuation of AKI in patients undergoing on-pump cardiac surgery. The primary objective is to assess the percentage of subjects with AKI within seven days following surgery, using KDIGO criteria. The trial includes clinical sites in Turkey and Canada, with hospitals such as Toronto General Hospital, St. Michael’s Hospital, and University of Calgary Hospital participating or preparing to participate.
• PONTIAK / PONTIAC Phase II trial (cilastatin) – An investigator-led Phase II trial titled “Prevention Of NephroToxin Induced Acute Kidney Injury with Cilastatin,” based at hospital sites in Alberta, Canada. The study is designed to evaluate cilastatin’s efficacy in preventing AKI associated with nephrotoxic pharmaceuticals, including antibiotics, chemotherapy agents, and imaging dyes that are known to cause kidney damage as a side effect. Arch provides the stand-alone cilastatin drug product and scientific and regulatory support, while the clinical team has secured funding from the Canadian Institutes of Health Research (CIHR) and the Accelerating Clinical Trials (ACT) initiative.
• CKD pre-clinical program (IL-32) – A platform focused on chronic kidney disease, particularly diabetic CKD, based on a mechanistic understanding of disease pathways involving IL-32. Arch notes that this program is pre-clinical and that its patents and therapeutic approaches are designed to create “on-target” CKD candidates that differ from many existing renal therapies, which often rely on off-target effects of drugs originally developed for other indications.

Scientific Rationale and Mechanisms

Arch Biopartners’ disclosures emphasize mechanism-based drug development grounded in peer-reviewed research. For LSALT peptide, the company cites work published in the journal Cell describing DPEP-1 as a leukocyte adhesion receptor on lung, liver, and kidney endothelium, and a Science Advances publication titled “Dipeptidase-1 governs renal inflammation during ischemia reperfusion injury,” which supports using LSALT peptide to prevent ischemia-reperfusion injury in the kidneys.

The company also references a peer-reviewed publication in BMJ Open that reported clinical and biomarker results from an earlier Phase II trial of LSALT peptide in hospitalized patients with acute lung and kidney inflammation caused by SARS-CoV-2 infection. That study provided first in-human evidence validating DPEP1 as a therapeutic target for organ inflammation and reported reductions in inflammatory biomarkers, including CXCL10, in patients treated with LSALT peptide.

For cilastatin, Arch points to pre-clinical research published in The Journal of Clinical Investigation in which cilastatin was shown to inhibit leukocyte recruitment and drug toxin uptake in the kidney, thereby preventing AKI caused by radiographic contrast. This research underpins the company’s strategy to repurpose cilastatin as a treatment for toxin-induced AKI.

In its CKD program, Arch highlights the discovery that IL-32 is directly implicated in diabetic CKD pathogenesis and that IL-32 is a lipid droplet-associated mediator of tubular injury in diabetic kidney disease, as summarized in an abstract published in the Journal of the American Society of Nephrology. The company presents IL-32 as a promising therapeutic target linking metabolic dysregulation to chronic inflammation in CKD.

Focus on Unmet Medical Needs in Kidney Care

Across its disclosures, Arch Biopartners repeatedly notes that there is no specific therapeutic treatment available in the market that prevents AKI, including AKI related to cardiac surgery and drug toxins. The company states that AKI can range from mild injury to complete loss of renal function, sometimes requiring dialysis or kidney transplantation, and that drug toxins and CS-AKI together account for a substantial share of in-hospital AKI cases.

For chronic kidney disease, Arch cites external epidemiological research indicating that CKD affects hundreds of millions of people worldwide and tens of millions in the United States, with diabetes as a leading cause. The company positions its IL-32 CKD platform as an “on-target” approach that is distinct from many current renal therapies based on off-target actions of drugs originally designed for blood pressure, blood sugar, or cardiovascular conditions.

Corporate and Capital Markets Context

Arch Biopartners is headquartered in Toronto, Canada, according to its news releases. It reports its common shares outstanding periodically in its public communications and notes that it has received non-dilutive funding and grant support for several of its trials, including contributions from NRC-IRAP for the LSALT peptide CS-AKI trial and CIHR and ACT funding for the cilastatin PONTIAK trial.

In addition to its listings on the TSX Venture Exchange and OTCQB, the company directs investors to its investor hub and public documents filed on SEDAR+ for further financial and regulatory information. The news releases also mention collaborations with academic and clinical institutions such as the University of Calgary, University of Alberta, University Health Network, and Unity Health Toronto, as well as the National Research Council of Canada.

Position Within the Biotech and Kidney Therapeutics Space

According to its own statements, Arch Biopartners is focused on preventing acute kidney injury and organ damage caused by inflammation and toxins and on developing new treatments for chronic kidney disease. The company emphasizes its nephrology expertise and describes its kidney drug portfolio as addressing both acute and chronic indications, including CS-AKI, toxin-induced AKI, and diabetic CKD.

Arch characterizes LSALT peptide as a first-in-class DPEP1 inhibitor for inflammation-driven organ injury and cilastatin as a repurposed drug particularly suited to toxin-related AKI due to its off-target effects on toxin uptake. The IL-32 CKD platform is presented as a next-generation approach for CKD candidates based on a novel mechanism of action directly implicated in disease progression.

FAQs About Arch Biopartners Inc. (ACHFF)

• What does Arch Biopartners Inc. do?
  Arch Biopartners Inc. is a therapeutic biotech company developing novel drugs for acute and chronic kidney diseases and for organ damage caused by inflammation and toxins. It focuses on drug candidates that target the dipeptidase-1 (DPEP1) pathway and related mechanisms in the kidneys, lungs, and liver.
• What are Arch Biopartners’ main drug candidates?
  The company highlights three main programs: LSALT peptide, a DPEP1 inhibitor in Phase II trials for cardiac surgery-associated acute kidney injury; cilastatin, a repurposed DPEP1 inhibitor being evaluated in a Phase II trial for drug toxin-related AKI; and a pre-clinical chronic kidney disease platform targeting IL-32, particularly in diabetic CKD.
• How does LSALT peptide work according to Arch Biopartners?
  Arch reports that LSALT peptide targets the DPEP1 pathway, which has been identified as a leukocyte adhesion receptor on lung, liver, and kidney endothelium. By inhibiting DPEP1, LSALT peptide is designed to prevent inflammation injury and ischemia-reperfusion injury in these organs, including the kidneys during on-pump cardiac surgery.
• What is cilastatin’s role in Arch Biopartners’ pipeline?
  Cilastatin is described as an enzymatic DPEP1 inhibitor originally approved as part of a fixed combination with imipenem to treat bacterial infections. Arch is repurposing cilastatin as a stand-alone drug product to prevent acute kidney injury caused by drug toxins, leveraging its off-target effects that block toxin uptake into kidney tissue.
• What is the IL-32 chronic kidney disease platform?
  The IL-32 CKD platform is a pre-clinical program acquired through the purchase of Lipdro Therapeutics Inc. It targets interleukin-32, which Arch and its collaborators have identified as directly implicated in diabetic CKD pathogenesis. The platform includes composition and method-of-use patents for new drug candidates that aim to provide on-target treatments for chronic kidney disease.
• Which medical needs is Arch Biopartners aiming to address?
  Arch focuses on areas where it states there are no specific therapeutic treatments available, including acute kidney injury related to cardiac surgery and drug toxins, as well as chronic kidney disease driven by specific inflammatory pathways. The company positions its pipeline as addressing significant unmet medical needs in global kidney care.
• On which exchanges does Arch Biopartners trade?
  Arch Biopartners’ common shares trade on the TSX Venture Exchange under the symbol ARCH and on the OTCQB market under the symbol ACHFF.
• How is Arch Biopartners funding its clinical trials?
  According to its news releases, Arch’s clinical programs are supported by a combination of company resources, non-dilutive funding, and external grants. Examples include NRC-IRAP support for the LSALT peptide CS-AKI trial and CIHR and ACT funding for the cilastatin PONTIAK Phase II trial, with Arch providing drug product and scientific and regulatory input.
• What collaborations does Arch Biopartners highlight?
  The company reports collaborations with academic and clinical institutions such as the University of Calgary, University of Alberta, University Health Network, and Unity Health Toronto, as well as scientific collaborations with the National Research Council of Canada. These relationships support its clinical trials and pre-clinical research.
• Is Arch Biopartners focused only on the kidneys?
  While Arch describes itself as a kidney therapeutics company and emphasizes kidney indications, it also notes that its DPEP1-targeting drugs, such as LSALT peptide, are being developed to prevent inflammation injury in the lungs and liver in addition to the kidneys.