Neovacs, a leader in active immunotherapies for the treatment of autoimmune diseases, has announced that South Korea’s health authority has approved the company’s Investigational New Drug application for IFNα Kinoid in Phase IIb development in Lupus.
Miguel Sieler, CEO of Neovacs commented about this trial, which now includes South Korea: “The examination of our trial has been particularly detailed and has therefore taken into consideration the innovative character of our technology in the frame of the development of a new therapeutic approach for a rare disease. Indeed, the Korean health authorities were very demanding and wanted to analyse and clearly understand the mechanism of action and the preclinical and clinical data obtained so far, as well as the different steps of production. This result is now an expression of confidence, which is encouraging for the future.”
Neovacs has indeed signed a licensing and partnering agreement with the Korean company, Chong Kun Dan Pharmaceuticals (CKD), leader in South Korea in the field of immunosuppressive drugs. South Korea is the only OECD country where Lupus disease meets the requirements to obtain orphan disease status. As such, within this agreement, Neovacs will soon file for “Orphan Drug Designation.” And, pending the success of its Phase IIb trial, the registration of the product and its launch in the Korean market could possibly take place without a Phase III trial.
Based on these criteria, receiving an IND is of strategic importance for Neovacs and for CKD as they prepare to launch IFNα Kinoid in the Korean market. This current Phase IIb trial, which is randomized, placebo-controlled and involves 166 patients, covers more than 100 investigation centres around the world, including five in South Korea. The results of this trial are expected in the summer of 2017.