Neovacs enrolls patients for lupus treatment study, results in 2018
June 20, 2017Neovacs has completed patient enrollment for for its phase IIb clinical study, IFN-K-002, evaluating IFNalpha Kinoid for the treatment of lupus.
The French company focused on immunotherapies for the treatment of autoimmune diseases, on Tuesday said that this confirms interest of leading clinicians conducting the trial. Therese Croughs, Chief Medical Officer of Neovacs, said that the company is expecting the results from the study in Q2-2018.
Study IFN-K-002 includes 178 patients who have moderate to severe systemic lupus erythematosus (SLE). This worldwide, randomized, multicentre international phase IIb study is evaluating IFNalpha Kinoid versus placebo and is being conducted under IND in Europe, Asia, North Africa, South America, and the United States. All the patients are being treated and followed up for 9 months for the main study.
Neovacs designed this Phase IIb clinical trial to obtain relevant and meaningful data on biological efficacy, by measuring the decrease of interferon gene signature, one of the primary markers of disease activity. Another goal is to test the clinical efficacy, by using the BICLA response score at Month 9. This score is one of the end-points validated by health authorities to evaluate the clinical response in lupus clinical studies, the company explained.
Neovacs said that this strategy promotes the recruitment of eligible patients in this phase IIb clinical trial in lupus, a rare and complex disease, with a number of patients worldwide estimated to 5 million.
