NEOVACS’ Investigational New Drug Application for Lupus Approved by South Korean Health Authority
French company NEOVACS announced that its Investigational New Drug (IND) application for IFNα Kinoid in lupus, now in Phase 2b development, was approved by the South Korean Health Authority.
NEOVACS was established in 1993. Today, the biotech is a leader in active immunotherapy technology platforms (Kinoids) for autoimmune and/or inflammatory diseases. NEOVACS is currently focusing its efforts in the clinical development of IFNα Kinoid, an immunotherapy indicated for systemic lupus erythematosus (SLE), so that patients can have access to safe, effective medicines in sustained, lifelong treatments.
The development of IFNα Kinoid is currently in a Phase 2b randomized and placebo-controlled clinical trial with 166 patients in over 100 centers worldwide, including five in South Korea. Results of the trial are expected by the end of June 2017.
“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,” said NEOVACS CEO Miguel Sieler in a press release. “Indeed the Korean health authorities were very demanding and wanted to analyze and understand clearly 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 also signed a licensing and partnering agreement with Chong Kun Dang Pharmaceuticals (CKD), a South Korean company that works in the field of immunosuppressive drugs. South Korea is the only country in the Organization for Economic Co-operation and Development (OECD) where SLE fulfills all the necessary requirements to obtain an Orphan Drug status, and NEOVACS plans to soon file for that designation.
If the current clinical trial is successful, it might accelerate the availability of the new product in the South Korean market — promising news for lupus patients.
SLE is a chronic, autoimmune disease which can be difficult to diagnose due to the lack of tests available and to the wide variation of clinical manifestations displayed by patients, as well as the diversity of genetic profiles observed. Disease heterogeneity contributes to a very limited success of clinical trials, which is why the completion of a successful clinical trial is a major achievement in SLE research.