NEOVACS recently was granted first approvals by regulatory agencies and ethics committees in several European countries for a Phase IIb clinical trial of IFN?-Kinoid in Systemic Lupus Erythematosus (SLE) or lupus.
The trial was assessed positively using the Voluntary Harmonization Procedure of Europe's Heads of Medicine Agencies, which permits for a consistent assessment of clinical trials by relevant national health authorities.
The acceptance allows Neovacs to begin IFN-K-002, a Phase IIb clinical study to assess the biological and clinical efficacy of Neovacs' lead active immunotherapy product candidate IFNa-Kinoid in patients suffering from lupus. Enrollment of the first patients is expected to begin in the coming weeks.
Approvals from other European, Asian and Latin American countries are expected in the second half of this year.
IFN-K-002 is a double-blind, randomized, placebo-controlled multicentric Phase IIb clinical trial designed to assess the efficacy and safety of IFNa-Kinoid in moderate to severe lupus patients. The study will recruit 166 patients across 19 countries in Europe, Asia and Latin America.
Neovacs is a biotechnology company focused on an active immunotherapy technology platform with applications in autoimmune and/or inflammatory diseases.
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