Updated on 20 August 2012
AbGenomics gets nod for phase II trial
Singapore: US-based firm AbGenomics International, which has subsidiaries in Taiwan and the Netherlands, 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.
Our 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 or 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 multicenter, placebo-controlled, double-blind trial.
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.