The world’s goal is to find medicines to treat dementia. Recently, there has been a ray of hope, especially in the United States.fdaLast year, “several indications were approved for the treatment of”Alzheimer’s disease” Medicines. However, Su Yiren, chair professor of Southern Taiwan University of Science and Technology in Taiwan and honorary researcher of the National Institutes of Health, believes that identifying the “upstream” pathogenic mechanism of Alzheimer’s disease is the key to developing drugs, Combinations of existing antibody drugs and drugs that improve nerve conduction symptoms are the future direction.
Su Yiren said that in October last year, the official magazine “Sail” published an article in San Francisco, USUniversity of CaliforniaAn article jointly published by Professor Adam Boxer and Professor Risa Sperling of Harvard University states that over the past 30 years, “the amyloid/tau protein theory has been the mainstream in developing drugs for Alzheimer’s disease (AD). It Now one stage has been reached.” ,
The US FDA will approve an antibody drug in 2022 and 2023, and may also approve an antibody drug from Eli Lilly in the first half of this year. However, over the past thirty years, there has been a long journey in the development of new drugs for disease-modifying AD, and about 95% of them failed in the second and third clinical stages.
Su Yiren said that the above-mentioned anti-amyloid antibody drugs approved by the US FDA still have reservations in disease treatment efficacy and side effects. Furthermore, they are expensive and inconvenient to use, and they also face challenges in the medical and insurance markets. Biogen announced last week that it would abandon its AduHelm antibody drug, throwing a blow to the future development of anti-amyloid antibody drugs.
However, Su Yiren pointed out that although the development of AD drugs in the past 30 years has not been smooth, a lot of valuable experience and new knowledge has been accumulated during the clinical trial process, which established the role of amyloid protein Is. Pathogenesis of AD.
Su Yiren believes that in the past five years, in addition to amyloid/tau protein, new AD pathogenesis mechanisms have made revolutionary progress. In Cell Reviews and other literature, directions for the development of new drugs for AD over the next century are also proposed, including research on aging biology such as oxidative stress, mitochondrial function, and autophagy function, as well as metabolism and inflammation. .
However, the development of new drugs from academic research to clinical trials takes a long time and is expensive, which academic institutions and small biotech companies cannot afford. Su Yiren said education and production for a series of industrial development processes from academic research, preclinical development, phase one clinical trials safety assessment to phase two and three clinical trials to confirm efficacy, as well as drug production. Is required. The technical community and large pharmaceutical companies, especially the provision of government funding and coordination of regulations and policies, are important.
How long will it take for a new generation of AD drugs to be successfully developed? This is a question that is currently being asked by the medical community and many investors. Due to new knowledge and clinical trial understanding, particularly the application of blood biomarkers in AD diagnosis, development time can be greatly reduced. It may only take five to ten years, however, to successfully develop ideal new drugs for the treatment of AD, especially ideal drugs that can restore normal aging in preclinical and early-stage patients, says Su Yiren. Believe that this is still a big challenge.
Su Yiren said that based on the existing scientific and clinical trial data, all parties have gradually reached a consensus and direction, which is to target the main “upstream” pathogenic mechanism of AD instead of the current antibody drugs. Find out which can only clear the extracellular matrix. Amyloid “plaque”.
The representative work of this new theory is the “autophagolysosome” regulation theory proposed by Professor Ralph Nixon of New York University in “Nature NS” in 2022, which advocates the removal of amyloid accumulation “intracellular”. This revolutionary new knowledge has now happened. has become a popular direction for the development of new AD drugs. Su Yiren also said that improving oxidative stress, glandular function and inflammation, as well as current symptomatic drugs that improve nerve conduction all have helpful effects to a certain extent.
Su Yiren said that the two master professors in the “Cell” article optimistically proposed the future direction of new drug development and clinical trial improvement methods, which will lead to comprehensive treatment for AD new drugs in the near future Combination with current antibody drugs is expected to accelerate completion. The future in response to increasing population. Following the growing global medical burden and market demand.
Health(TagstoTranslate)Alzheimer’s Disease(T)FDA(T)University of California