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Class 1.1 new chemical drug piperidone "AD16” has been accepted by CFDA IND

2015-01-15
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Alzheimer’s disease, the English name is Alzheimer’s disease (Alzheimer disease), abbreviated as AD is a neurodegenerative disease with insidious onset and progressive development. Clinically, it is characterized by general dementia such as memory impairment, aphasia, apraxia, agnosia, impairment of visual spatial skills, executive dysfunction, and personality and behavior changes. The etiology is still unknown. Those who develop the disease before the age of 65 are called Alzheimer’s disease; those who develop the disease after the age of 65 are called Alzheimer’s disease. The incidence rate in my country is about 5%, and it mostly occurs in people over 65 years of age. The number of patients affected is about 6 million, and the number is increasing at an annual rate of 300 to 400 thousand.

At present, there is no specific medicine to treat Alzheimer’s disease, and the development of drugs for the prevention and treatment of Alzheimer’s disease has become a top priority. In the United States, dementia has become the third most expensive disease after heart disease and cancer. Major pharmaceutical research and development companies are investing a lot of manpower and material resources to overcome this problem. The US government also invests in social costs of dementia as high as 100 billion US dollars every year. . Once the Chinese market is awakened, it will be unimaginable. Even if it is conservatively estimated that the market demand will reach more than 20 billion annually, the market prospects are broad.

Recently, the Guangzhou Institute of Medicine and Health of the Chinese Academy of Sciences (Health Institute) and the Guangdong South China New Drug Innovation Center (referred to as the Center) Class 1.1 new chemical drug piperidone (“AD16”) have been formally accepted by the State Food and Drug Administration, applying for clinical new drug the study.

When the research and development of drugs for Alzheimer’s disease is in a dilemma (a number of such highly anticipated drug candidates failed in Phase III clinical trials), neuroinflammation inhibitors may become another important idea in the research and development of senile dementia drugs, which is expected to improve the elderly The success rate of dementia drug development. A large number of research results show that in Alzheimer’s, neuroinflammation caused by excessive activation of microglia is the most direct cause of neuronal function abnormalities and cognitive decline. Therefore, taking neuroinflammation as a target, inhibiting the excessive activation of microglia and the release of pro-inflammatory cytokines can effectively prevent the deterioration of the disease.

Piperidone is a highly active new type of neuroinflammation inhibitor screened out by microglia phenotype in vitro. Preclinical studies in a variety of animal models have confirmed that piridoxone can significantly reduce the damage to neuronal cells caused by factors such as amyloid or cerebrovascular, improve the memory and cognitive impairments of different Alzheimer’s animals, thereby controlling the development of Alzheimer’s disease deterioration. Some indicators are better than the current commonly used clinical drugs donepezil and memantine. Even in the transgenic mouse model of moderate to severe Alzheimer’s disease, it also showed a significant protective effect on hippocampal neurons and synapse ultrastructure damage. In addition, the pre-clinical safety evaluation results also show that the drug has a wide range of safety, simple metabolites, and good druggability and development prospects.

Medicilon is responsible for the pharmacokinetics and safety evaluation of this project. The pre-clinical safety evaluation results show that the drug has a wide range of safety, simple metabolites, and good druggability and development prospects.

According to data released by the China Alzheimer’s Association in 2013, there are currently more than 6 million Alzheimer’s patients in China. The successful development of piperidone will bring new hope to patients with senile dementia and also create a new development direction for the treatment of senile dementia.

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