On Monday (November 6th) Eastern Time, Dr. Daniel Skovoronsky, the chief scientist of Eli Lilly (NYSE: LLC, stock price $595.19, market value $565 billion), the world's highest pharmaceutical company by market value, expressed "extreme optimism" in an interview with MarketWatch that a major breakthrough in Alzheimer's disease is imminent, Donanemab, a drug, may become the next hot topic similar to weight loss pills (GLP-1). Skovolonsky stated that according to experimental data, Lilly's drug donanemab not only slows down disease development but also has the potential to prevent the onset of Alzheimer's disease. Driven by his exclusive interview, Lilly closed up 4.82% on Monday, with a market value increase of $26 billion in one trading day.
For many years, drug development for Alzheimer's disease (commonly known as Alzheimer's disease) has been a challenging topic for the global pharmaceutical industry. At present, over 30 million people worldwide are suffering from Alzheimer's disease, and the number of this group is expected to continue to grow. However, the development of drugs for treating Alzheimer's disease has been quite slow. At the beginning of this year, although the US Food and Drug Administration (FDA) approved the second new Alzheimer's disease drug, lecanemab, in nearly 20 years, its safety issues still need to be addressed: some participants experienced brain swelling and bleeding. In the past few months, the global medical community has been waiting for FDA approval for donanemab.
The FDA is expected to make a decision on Donanemab by the end of the year
As the Chief Scientist and Chief Medical Officer of Lilly, Skovolonsky has always been a pioneer in the field of drug innovation. Driven by significant progress in the treatment of Alzheimer's disease and obesity, Lilly is currently the world's largest pharmaceutical company by market value, with a market value of $565 billion as of Monday's close, far surpassing a group of pharmaceutical giants such as Pfizer ($176 billion), Merck Pharmaceuticals ($264.8 billion), and Johnson&Johnson ($365.2 billion).
Lilly's stock price has risen by over 60% this year at Yahoo Finance
The Daily Economic News reporter noticed that Lilly and its competitors' rapid innovation in drugs has also sparked considerable controversy. Researchers, policy makers, and industry participants are all debating whether the potential benefits of next-generation Alzheimer's disease drugs outweigh their costs and risks.
In the midst of such questioning, Skovolonsky still focuses on drug innovation. He pointed out in an interview with MarketWatch that Lilly's experimental Alzheimer's disease therapy has the potential to prevent the onset of Alzheimer's disease, rather than just slow down its progression, as shown in clinical trial data released by Lilly earlier this year.
If Skovolonsky's innovative therapy is approved, it will bring a significant breakthrough in the early diagnosis and effective treatment of Alzheimer's disease, a devastating disease. In the United States, approximately 6.7 million elderly people aged 65 and above suffer from this disease. Skovolonsky published his research on this field as early as 1998, when he was still at the University of Pennsylvania School of Medicine. Subsequently, he founded a company called Avid radiopharmaceuticals and developed a diagnostic reagent to help evaluate Alzheimer's disease patients.
This is actually my lifelong job, "Skovolonsky said. The donanemab being developed by Lilly is a targeted N3pG (a modified type) β Antibody drugs for amyloid protein. The drug has shown significant efficacy in phase 3 clinical trials, which can slow down cognitive and functional decline in early Alzheimer's disease patients. Lilly has submitted its listing application for donanemab to the US Food and Drug Administration (FDA), and it is expected that the FDA will make a decision before the end of 2023. If approved, donanemab will become the three immunotherapies for Alzheimer's disease, following the lecanemab of Eisai and Bojian.
Skovolonsky stated that the effect of donanemab in delaying Alzheimer's disease is "really significant". For example, in a clinical trial, nearly half of patients receiving donanemab treatment did not lose any cognitive abilities after one year, which is "significant".
Despite its significant effects, the safety issues of this new drug cannot be ignored. Phase 3 clinical trial data showed that in the donanemab treatment group, the incidence of amyloid associated imaging abnormalities (ARIA) was 1.6%, including two participants who died due to ARIA and one participant who died after a severe ARIA event. According to foreign media reports, some geriatric doctors are not very interested in donanemab and lecanemab. They believe that it is not clear whether the benefits of these two drugs are sufficient to outweigh the huge costs and risks they bring, including potential brain swelling or bleeding.
In addition, Lilly is also developing an oral β Secretory enzyme lyase (BACE) inhibitor, named E2609. This drug can reduce the activity of BACE enzyme by inhibiting it β The generation of amyloid protein can prevent or delay the development of Alzheimer's disease. The drug is currently undergoing phase 3 clinical trials, recruiting approximately 2100 early Alzheimer's disease patients worldwide.
Extended Reading
The latest research suggests that oxygenated graphene may alleviate Alzheimer's disease
Alzheimer's disease is a common neurodegenerative disease characterized by a gradual loss of memory, thinking, and behavioral abilities. According to data from the World Health Organization, there are currently over 55 million people worldwide (8.1% of women and 5.4% of men aged 65 and above) suffering from dementia, with Alzheimer's disease accounting for 60% -70%. It is estimated that the number of dementia patients worldwide will increase to 78 million by 2030 and 139 million by 2050.
At present, the treatment of Alzheimer's disease mainly includes drug therapy and non drug therapy. There are two main types of drug therapy: cholinesterase inhibitors and memantines, which can alleviate symptoms of memory and cognitive impairment by improving communication between brain cells, but cannot prevent the progression of the disease. Non drug therapy includes cognitive training, lifestyle interventions, and psychosocial support, with the aim of improving patients' quality of life and self-care abilities, and reducing the burden on families and society.
In recent years, new treatment methods are being developed for the pathological mechanism of Alzheimer's disease, with the most noteworthy being immunotherapy targeting amyloid plaques in the brain. Amyloid plaques are typical pathological markers of Alzheimer's disease, which may impair the function and survival of brain cells. The principle of immunotherapy is to use monoclonal antibodies to recognize and clear amyloid proteins, thereby preventing or delaying the development of the disease. Currently, two immunotherapy drugs have been approved by the FDA in the United States, namely Aduhelm and lecanemab. Both drugs are administered intravenously and require regular brain imaging examinations to monitor their efficacy and side effects. At present, the effectiveness and safety of these two drugs are still controversial and require more clinical data to confirm.
Alzheimer's disease is a complex disease, and its causes and mechanisms are not yet fully understood. Therefore, multidisciplinary cooperation and innovation are needed to find more effective prevention and treatment methods. At the same time, increasing public awareness and attention to Alzheimer's disease, strengthening early screening and diagnosis, and establishing a fully stratified medical model are also important measures for preventing and treating Alzheimer's disease.
However, some studies suggest that misfolded β- Amyloid protein peptide (i.e. A β Peptides accumulate and aggregate in the brain, which is believed to be the fundamental cause of Alzheimer's disease. They trigger a series of harmful processes in neurons (brain cells), leading to the loss of important cell function or cell death, resulting in the loss of brain function in the affected area. So far, there is no effective strategy to treat amyloid accumulation in the brain. But researchers from Chalms University of Technology in Sweden have now shown that treating yeast cell models with graphene oxide can reduce the aggregation level of amyloid peptides. The research results were published in the journal Advanced Functional Materials in July.
According to Xin Chen, a systems biology researcher at Chalmers University of Technology and the first author of the study, The effect of graphene oxide has recently been demonstrated by other researchers, but not in yeast cells. Our study also explains the mechanism behind this effect. Graphene oxide can affect cell metabolism, increase cell resistance to misfolding proteins and oxidative stress. This has not been reported before