Neovacs, a leader in active immunotherapies for the treatment of autoimmune diseases, announced that South Korea health authority approved Neovacs’s Investigational New Drug application for IFN Kinoid in phase IIb development in Lupus.
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. This country is the only one of the OECD where Lupus disease fulfills the requirements to obtain the orphan disease status. Within this agreement Neovacs will file in a near future for “Orphan Drug Designation”. In case of success of its phase IIb trial the registration of the product and its launch in the Korean market could as consequence take place without a previous phase III trial.
Based on these elements having received this IND is of strategic importance for Neovacs and for CKD in order to launch IFN Kinoid in the Korean market.
This actually running phase IIb trial, randomized, versus placebo and concerning 166 patients, covers more than 100 investigation centers in the world, including now 5 in South Korea. The results of this trial are expected for summer 2017.
