Stroke is a severe disease which is characterised by sudden onset and followed frequently by death or prolonged disabilities of the patients. Stroke is ranked number two worldwide as cause of death, and is Europe's thirdmost cause for disabilities and invalidity.
The most common form of stroke is brain ischemia (85 percent). It is caused when the blood supply of the brain is disrupted, followed by oxygen and glucose deprivation of the affected brain area. Following the reduced blood supply, massive neuronal cell death occurs and inflammatory and edematous processes are activated, which further increase the lesion and the infarct area. The patients suffer mostly from motor impairment such as weakness of the limb or paralysis, but also from speech and visual disorders. Besides the ischemic stroke which is caused by the obstruction of a blood vessel, hemorrhagic stroke is a second form of stroke caused by a bleeding into the brain parenchyma. General risk factors for stroke are old age, elevated blood pressure, smoking, reduced physical activity, increased body weight, and elevated levels of lipids in the blood.
Currently, only one therapy is approved for the treatment of acute stroke: lysis of the blood clot obstructing the vessel by tissue plasminogen activator (t-PA). A drawback of the currently approved lysis therapy is that it can only be applied within three hours after the onset of symptoms. Combined with the extensive diagnostic proceedings necessary to diagnose stroke and to exclude other reasons of disease, only two to three percent of stroke patients receive lysis therapy. All other therapeutic approaches aim at reducing further ischemic events (heparin, acetylsalicylic acid (ASS, aspirin), blood pressure monitoring). For the majority of the patients, there is no therapeutic option.
With regard to the 1.8 million new stroke patients every year worldwide, and 250,000 new patients in Germany alone, this is not satisfactory. However, a number of patients do see an improvement of symptoms and impairments in the course of rehabilitation and training based on the tremendous potential for regeneration and restructuring in injury and insult. The endogenous plasticity can be further improved by physical therapy and logopedics.
With AX200, SYGNIS has developed a medication in late clinical phases, addressing multiple aspects of the disease. AX200 protects neurons from cell death and also improves blood flow in the infarct area. Furthermore, AX200 promotes the regeneration of neurons by stimulating adult stem cells and the reorganization of the brain tissue (plasticity).