Neovacs has reported results from a Phase IIb clinical trial of IFNα Kinoid for the treatment of patients with moderate-to-severe lupus (SLE).
The double-blind, randomised, placebo-controlled, multi-centre trial enrolled 185 patients in Europe, Asia, the US, North Africa, and Latin America.
Primary endpoints of the trial were biological efficacy and clinical efficacy nine months after the first treatment with IFNα Kinoid.
The trial’s main secondary endpoints for assessing clinical efficacy included SRI-4 with steroid reduction of 5mg/day, as well as Lupus Low Disease Activity Score (LLDAS).
During the study, the patients were randomised to provide either IFNα Kinoid or placebo intramuscular five times on the days one, seven, and 28, and then at three and six months.
Patients were also provided standard treatment with antimalarials, immunosuppressants and/or steroids.
Following this primary evaluation period, patients entered a five-year follow-up period to evaluate the safety, as well as the long-term biological and clinical efficacy of IFNα Kinoid.
Results of the evaluation demonstrated a very statistically significant biological efficacy of IFNα Kinoid, measured by the decrease of the interferon signature at week 36 of the study.
However, the clinical response in patients treated with IFNα Kinoid against those treated with placebo measured by the BILAG-Based Composite Lupus Assessment (BICLA) score at week 36, did not achieve a statistical improvement as defined in the primary objectives of the trial.
The Phase IIb trial scientific chairman Frédéric Houssiau said: “It is important to note the very marked effect of IFNα Kinoid on the LLDAS score, of which one of the five criteria is the reduction of steroid use.
“It suggests that one must take into account the reduction of steroid therapy, an important goal of treatment.
“This study demonstrates, once again, the difficulties in choosing the primary clinical endpoint in SLE.”
SLE is a debilitating, chronic autoimmune disease whose etiology is still unknown to scientists.