Neovacs announced that the full results of the phase IIb clinical study were presented on April 6, 2019, by Prof. Frédéric Houssiau, MD, PhD, Vice-Rector of the Faculty of Health Sciences at UCL (Université Catholique de Louvain), Brussels, Belgium,1 and chairman of the clinical study, at the first plenary of the international congress on Systemic Lupus Erythematosus, LUPUS 2019 (San Francisco, 5-8 April), during an oral session entitled: “IFN Kinoid in Systemic Lupus Erythematosus (SLE): Results from a Phase IIb, Randomized, Placebo-Controlled Study 2”. The results confirmed that treatment with IFN-alpha Kinoid induced a strong immune response: 91.4% of treated patients produce neutralising polyclonal antibodies against interferon alpha. This study also showed: A statistical trend observed on the SRI-4 clinical score,5 with corticosteroid reduction to =5 or 7.5 mg/day (p=0.07), which became statistically significant (p=0.04) in the subgroup of patients who developed neutralising antibodies against interferon alpha; A statistically significant clinical response (p=0.0022) based on the LLDAS score, with 52.9% responders in the treated group, versus 29.8% in the placebo group, i.e. a 23% difference; A marked difference in corticosteroid intake, i.e. 7.1 mg in the placebo group, versus 5.4 mg in the group of patients treated with IFNa Kinoid, at 36 weeks; A statistical trendon the improvement of fatigue in patients treated with IFN-alpha Kinoid (p=0.068). Fatigue is frequently reported in most chronic conditions. It affects almost 9 in 10 lupus patients. When lupus is active, fatigue is directly associated with the disease; Good tolerance of IFNa Kinoid. Serious adverse effects were more frequent in the placebo group (13%) than in the group treated with IFN-K (7%). Moreover, frequency and severity of non-serious adverse events were not different in both groups. The main adverse effects reported during the study were mostly related to the disease and to a local reaction at the injection site. The treatment with IFN-alpha Kinoid did not modify or worsen the risk of infection associated with lupus. All these highly encouraging results must be assessed further in a phase III clinical program.