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ARG201 is a biologic drug candidate consisting of native type I bovine collagen, developed by arGentis Pharmaceuticals for the treatment of late-stage diffuse cutaneous systemic scleroderma (dcSSc), also known as systemic sclerosis. The therapeutic approach utilizes oral immune tolerance, where the administration of the collagen antigen interacts with the Gut-Associated Lymphoid Tissue (GALT) to suppress the pathological autoimmune response against the patient's endogenous type I collagen. This mechanism aims to reduce the fibrosis of the skin and internal organs characteristic of the disease. ARG201 has completed Phase II clinical testing and is associated with the ROT1 genotype marker, which serves as a predictive biomarker for patient response.
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