AbGenomics International, a biopharmaceutical company, has obtained FDA agreement on Its Phase 2 clinical trial plans of the novel autoimmune therapeutic candidate, AbGn-168H.
The current Phase 2 AbGn-168H trial will be a multicenter, placebo-controlled, double-blind trial with the primary objective 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, according to the company.
The antibody has demonstrated a good safety profile in preclinical safety and phase 1 trial studies in both psoriasis patients and healthy volunteers.
A clear biological/pharmacological effect consistent with the proposed mechanism of action of AbG's antibody was demonstrated in SRD phase 1 psoriasis patient study.
