台醫antibody AbGn-168H phase II (FDA)

AbGenomics International Obtains FDA Agreement on Its Phase 2 Clinical Trial Plans  19 Aug 2012 First-in-class approach targets CD162 with novel action LOS ALTOS, CA, USA I August 17, 2012 I AbGenomics International announced today that it has obtained agreement from U.S. Food and Drug Administration (FDA) for its proposed plans for a phase 2 clinical trial of the novel autoimmune therapeutic candidate, AbGn-168H.Our antibody demonstrated a great safety profile in preclinical safety and phase 1 clinical trial studies in both psoriasis patients and healthy volunteers. In SRD phase 1 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 2 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. AbGenomics is a biopharmaceutical company focused on the discovery and development of novel medicines to treat diseases with unmet medical need and significant market potential. Currently, the company has two therapeutic candidates in clinical trials. Headquartered in San Francisco Bay Area, U.S., AbGenomics has subsidiaries in the Netherlands and in Taiwan. The Company's strategy is to commercialize its novel products in collaboration with major pharmaceutical partners in order to maximize the opportunity for development and marketing of the Company's compounds.SOURCE: AbGenomics