|Basic research phase||Non-clinical||Clinical Trial Phase||Approval|
|EIM-001||Peripheral artery diseases||Japan||
Peripheral arterial disease, the target disease of our pipeline is a disease in which narrowing or occlusion of arteries in the extremities leads to circulatory disturbances. The prevalence of lower extremity occlusive arterial disease in middle-aged and elderly people in Japan is estimated to be approximately 1% to 3%. When it’s mild, the disease is subclinical (Fontaine class I). In moderate cases, intermittent claudication develops (Fontaine class II), and in severe cases (chronic limb-threatening ischemia: CLTI) pain at rest (Fontaine class III) and ulcers/gangrenes (Fontaine class IV) develop. Fontaine classification IV often requires lower limb amputation.
The treatment strategies are based on the risk factors for arteriosclerosis. Exercise and drug therapy are recommended for patients with Fontaine class II, and when the improvements in the symptoms are poor, revascularization, such as endovascular treatment or surgical bypass, is considered. For patients with CLI, the results of wound evaluation (wound, ischemia, stage of infection) are considered to decide the treatments, e.g., wound care, revascularization, lower extremity amputation, etc. Surgical bypass, selected for patients with moderate or greater severity, is highly invasive. A new position of treatment is needed that can bridge exercise/drug therapy and surgical bypass. Recently, some gene- and cell-based angiogenesis therapies have become available as alternative treatments.
Our pipeline has one of the angiogenesis therapies, being developed to establish a treatment option that efficiently show local effects while minimizing invasiveness.
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