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AbGenomics International, a biopharmaceutical company focused on the discovery and development of novel medicines, has obtained agreement from US Food and Drug Administration (FDA) for its proposed plans for a phase II clinical trial of the novel autoimmune therapeutic candidate, AbGn-168H.
The primary objective of the study is to demonstrate that AbGn-168H provides safe, durable, and remissive therapeutic effect in psoriatic patients. Additional clinical trials for type-I diabetes, Crohn's and other autoimmune diseases are under evaluation.
This antibody demonstrated a great safety profile in preclinical safety and phase I clinical trial studies in both psoriasis patients and healthy volunteers. In SRD phase I psoriasis patient study, a clear biological/pharmacological effect consistent with the proposed mechanism of action of AbG's antibody was demonstrated in patients. The current phase II clinical trial of AbGn-168H will be a multi-centre, placebo-controlled, double-blind trial.
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