Neovacs has begun enrolment for its international Phase IIb clinical study of IFNalpha Kinoid to treat systemic lupus erythematosus (SLE).
SLE, or lupus erythematosus, is a debilitating, chronic autoimmune disease that causes self-antigens loss of tolerance, with the production of autoantibodies such as anti-nuclear antibodies that attack healthy tissues and cause inflammatory reactions in different parts of the body such as skin, kidneys, joints, heart, lungs and central nervous system.
A first clinical centre has begun to enrol patients in the study, which initially planned to include five investigation centres.
The trial has attracted interest from a large number of American sites and auto-immune disease specialists. Due to the demand, Neovacs plans to open additional centres, increasing the total number of trial sites to 15.
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This Phase IIb trial is part of a randomised, multicentric, international clinical study that began in September 2015.
The ongoing study is analysing IFNalpha Kinoid versus placebo in the treatment of systemic lupus erythematosus (SLE).
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Its aim is to evaluate assess the biological and clinical efficacy of IFNalpha Kinoid, a product in Neovacs' pipeline, in patients who have moderate-to-severe SLE.
The trial plans to include 178 patients in 21 countries in Latin America, Asia, Europe and the US.
Neovacs CEO Miguel Sieler said: "The enthusiasm among US investigators confirms the strong therapeutic interest in our product for the treatment of autoimmune diseases.
"Our lead drug candidate represents a potentially very interesting option for the treatment of lupus, an area where current therapeutic standards have failed to prove long-term efficacy.
"This is an area with a significant unmet medical need, and we look forward to continuing the study with the goal or providing a new therapeutic option for patients in need."
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