IFNα-Kinoid
Lupus : A major unmet medical need
Lupus is a chronic and severe autoimmune disease in which the immune system produces antibodies to cells within the body leading to widespread inflammation and tissue damage. It may affect multiple organ systems, including the skin, the joints, the heart, the lungs and the kidneys. It can result in arthritis, kidney failure, cardio-vascular and pulmonary problems, nervous system disorders, inflammation of the circulatory system and hematologic abnormalities. Lupus is a life-threatening disease, with mortality most frequently a result of secondary effects of the disease, most commonly glomerular nephritis leading to kidney failure. Lupus disease may first occur at any age, though peak diagnosis is between the ages of 15 and 40. It is far more common in women than men: approximately 90% of cases are diagnosed in women. Prevalence estimates for the disease vary widely, and range as high as 1.5 million in North America (the Lupus Foundation of America) and 5 million worldwide.
There is currently no targeted therapy for lupus: rather the treatment strategy is to control symptoms and prevent disease flares. This strategy relies on the use of corticosteroids and immunosuppressants, which have significant tolerability and toxicity issues in a chronic use setting. Some biologics are also used off-label, but their efficacy appears modest.
The cytokine Interferon α is widely thought to play a key role in causing Systemic Lupus Erythematosus (SLE)
The medical and scientific community has identified interferon alpha (IFNα) as playing a key role in some patients in the causation and development of Systemic Lupus Erythematosus (SLE). Hence, targeting IFNα could be a powerful therapeutic strategy in this chronic disease.
Our IFNα-Kinoid product candidate is in an ongoing Phase I/II study in lupus patients : the first results seem very encouraging, in that so far the product has been well tolerated by patients ; this is an important first step in demonstrating the safety of the product.
It is too early to discuss the efficacy of the IFNα-Kinoid in man for the treatment of lupus. However, preclinical studies in demanding animal models of the disease demonstrated a clear treatment effect in mice suffering from severe disease both in terms of symptomatic reduction and survival.(Zagury et al, PNAS 2009)
The IFNα-Kinoid has broad activity, addressing all 13 known sub-types of human IFNα
At this point, the role of each of the 13 subtypes of human IFNα in the development of lupus has not been determined. However, Neovacs has shown that antibodies produced by administration of the IFNα-Kinoid neutralize all 13 sub-types, and also neutralize IFNα in the serum of lupus patients. This breadth of activity support the positioning of the IFNα-Kinoid as a next-generation treatment with the goal of stopping the development of disease in this serious and lifelong condition.
Phase I/II clinical trial in lupus patients: rapid progress, with very encouraging tolerability findings to date
The IFNα-K-001 Phase I/II clinical study in lupus patients began in April 2010 and has progressed as planned. To date, three dose levels have been administered and been shown to be well-tolerated. As of early 2011, a fourth and higher dose level is in the process of being administered to a new patient cohort. Patient enrollment will be complete in the first quarter of 2011.
Preliminary results from this double-blind, placebo controlled study will be available in mid-2011.
Source : Zagury D. et al., 2009, PNAS
