Paris and Boston, September 24, 2015 – NEOVACS (Alternext Paris: ALNEV), a leader in active immunotherapies for the treatment of autoimmune diseases, announced today it has begun enrolling patients in IFN-K-002, a Phase IIb clinical trial to evaluate the efficacy of IFNα-Kinoid, Neovacs’ lead active immunotherapy product candidate, to treat Systemic Lupus Erythematosus (“SLE” or “lupus”).
“With the initiation of this Phase IIb study, we have reached an important milestone in the development of IFNα-Kinoid. The first centers of the trial are now up and running, with more centers planned to open in the coming weeks, which will accelerate the recruitment for the study. IFN-K-002 is a key trial for Neovacs, and for our active immunotherapy approach to the treatment of lupus. Lupus affects millions of patients worldwide, most of whom have no access to biological treatments” commented Miguel Sieler, CEO of Neovacs.
Phase IIB trial design for IFN-K-002 in SLE
IFN-K-002 is a double-blind, randomized, placebo-controlled, multi-center Phase IIb clinical study to assess the biological and clinical efficacy of IFNα-Kinoid in patients suffering from SLE. The study aims to enroll 166 patients in Europe, Asia and Latin America. The co-primary endpoints for the trial are biogical efficacy and clinical efficacy nine months after first treatment with IFNα-Kinoid. Biological efficacy is defined as IFNα-signature neutralization, while clinical efficacy will be measured by the BILAG-based Composite Lupus Assessment (BICLA) response.
Results of the clinical trial are expected in the first quarter of 2017.
 The British Isles Lupus Assessment Group (BILAG) is a validated index to measure lupus disease activity listed in FDA guidance on lupus. See FDA Systemic Lupus Erythematosus working group report at : www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM072063.pdf#sthash.qR2f2REj.dpuf