Arch Strengthens its Position as a Leading Kidney Therapeutics Company With Acquisition of Breakthrough Platform to Develop New Drugs Targeting Chronic Kidney Disease

Arch Biopartners Inc. recently announced it has acquired a pre-clinical platform developing new drugs to treat chronic kidney disease (CKD). The platform includes recently filed patents protecting new compositions and methods targeting a novel mechanism of action involving interleukin-32 (IL-32), which is directly implicated in the progression of CKD.

Farris Smith, Strategic Advisor to Arch and former CFO of Novo Nordisk Canada, said“This new chronic kidney disease program expands the commercial potential of Arch’s kidney drug development pipeline. The assets underlying the CKD program could provide novel, on-target treatment options for a significant unmet need in a major pharmaceutical market. Combined with Arch’s existing acute kidney injury programs, Arch is better positioned for potential new partnership opportunities that can accelerate development and drive long-term value for the Company.”

Richard Muruve, CEO of Arch Biopartners, added “Our entry into the CKD drug development business is a natural evolution for our team that has a strong core competency in nephrology. Today’s news makes Arch Biopartners’ kidney drug portfolio more vital to patients and more valuable to the pharmaceutical industry.”

Arch obtained the new CKD assets through the acquisition of all outstanding shares of Lipdro Therapeutics Inc. (Lipdro), a private Alberta based company and arm’s length to the Company, in return for 250,000 common shares of Arch at a deemed price of $1.85 per common share and a royalty on net sales in the future, and subject to final approval by the TSX Venture Exchange. Dr. Justin Chun, MD, PhD, founder and 100% owner of Lipdro, joins the Company as a Principal Scientist to lead development of the new Arch CKD platform. The common shares, when issued to Dr. Chun following today’s announcement, will be subject to a four month hold period.

The therapeutic platform acquired by Arch specifically targets interleukin-32 (IL-32), a non-classical cytokine involved in regulating inflammation and immune responses. In pre-clinical studies, Dr. Chun and his scientific team discovered that IL-32 is directly implicated in the pathogenesis of diabetic CKD. New drug compositions were subsequently invented through a collaboration involving the National Research Council of Canada (NRC), Lipdro, and Arch scientists, and exclusively licensed to Arch by the NRC. Additional therapeutic approaches involving IL-32 were developed and patented by Dr. Chun and Arch scientists and assigned to Arch.

Dr. Daniel Muruve, Chief Science Officer at Arch Biopartners and Professor, Cumming School of Medicine, University of Calgary, said “We are excited to welcome Dr. Chun to the Arch science team as a Principal Scientist and leader of the IL-32 CKD program. His deep scientific knowledge as a nephrologist and his leading expertise in working with patient-derived kidney organoids will be invaluable as Arch develops novel therapeutics targeting chronic kidney disease.”

These patents are a significant addition to Arch’s kidney drug asset portfolio. The IL-32 CKD program deepens the Company’s portfolio for developing new treatments for kidney diseases and injury. The new program introduces a novel therapeutic approach for diabetic CKD, the most common cause of kidney failure globally. The therapeutic platform is based on a mechanistic understanding of disease pathways and builds on Arch’s expertise in renal inflammation and organ protection.

Dr. Chun said “Targeting the underlying mechanisms of inflammation and fibrosis that drive CKD is critical for preventing irreversible structural organ damage and slowing the progression toward kidney failure. In this context, our discovery of IL-32 as an intracellular, unconventional cytokine that links metabolic dysregulation to chronic inflammation represents a promising therapeutic target and opens new avenues for halting the progression of CKD, including diabetic kidney disease.”

An overview of the IL-32 mechanism of action related to diabetic-CKD is summarized by Dr. Chun and his collaborators in the following abstract published in the Journal of the American Society of Nephrology: IL-32 Is a Lipid Droplet-Associated Mediator of Tubular Injury in Diabetic Kidney Disease.

CKD affects more than 800 million people worldwide and approximately 35 to 38 million in the US. Diabetes is the leading cause, responsible for an estimated 30% to 40% of all CKD cases. Diabetic CKD leads to kidney failure, and several other major comorbidities, including cardiovascular disease. Many current renal therapies are based on unanticipated “off-target” actions of drugs originally designed to control blood pressure, blood sugar, and cardiovascular complications rather than targeting specific biological pathways in the kidney that drive disease.

Arch’s newly acquired “on-target” CKD platform stands apart from many drugs in use today and may represent the next generation of CKD candidates for clinical development in the pharmaceutical industry.

Arch Biopartners Inc. is a therapeutic biotech company developing novel drugs for acute and chronic kidney diseases. The Company is advancing an integrated pipeline that includes new treatments targeting inflammation- and toxin-induced kidney injury. The company’s programs include a pre-clinical chronic kidney disease platform targeting IL-32 (announced today), LSALT peptide, a first-in-class DPEP1 inhibitor in Phase II for preventing cardiac surgery-associated acute kidney injury, and cilastatin, a repurposed drug in Phase II for preventing toxin-induced kidney damage. These assets represent distinct, mechanism-based approaches to treating and preventing common causes of kidney damage. Together, they target serious unmet needs in kidney care across both chronic and acute indications, affecting millions of patients worldwide. For more information, visit www.archbiopartners.com/our-science.