Difficult AD R&D road Takeda Alzheimer's disease phase III trial failed
January 26, 2018 Source: Sina Pharmaceutical
Window._bd_share_config={ "common":{ "bdSnsKey":{ },"bdText":"","bdMini":"2","bdMiniList":false,"bdPic":"","bdStyle":" 0","bdSize":"16"},"share":{ }};with(document)0[(getElementsByTagName('head')[0]||body).appendChild(createElement('script')) .src='http://bdimg.share.baidu.com/static/api/js/share.js?v=89860593.js?cdnversion='+~(-new Date()/36e5)];Takeda Pharmaceutical announced that an experimental study of advanced Alzheimer's disease (AD) failed. After the interim analysis, Takeda Pharmaceuticals and development partner Zinfandel Pharmaceuticals has completed the five-year third phase TOMMORROW trial.
The two companies said the results of the analysis showed that the study drug pioglitazone 0.8 mg SR had insufficient therapeutic effect on delaying mild cognitive impairment (MCI) caused by Alzheimer's disease. The biomarker risk allocation algorithm, as a risk predictor, was evaluated in a phase III clinical trial to predict that a cognitively normal individual (65-83 years old) presents a risk of MIC caused by AD within the next 5 years. . Although age and ApoE status have previously been shown to indicate an increase in MCI risk in AD, the inclusion of TOMM40 in the projections is expected to further improve AD risk measures.
In 2011, Takeda and Zinfandel Pharmaceuticals reached an exclusive global licensing agreement for the TOMM40 test developed by the latter. The TOMM40 biomarker was discovered by Zinfandel Pharmaceuticals and is currently being developed to identify high-risk individuals presenting AD within the next 5 years.
Emiliangelo Ratti, head of neuroscience treatment at Takeda, said, "The two companies will analyze the data, including the performance of genetic-based biomarker risk allocation algorithms. It is hoped that these data will ultimately drive the development of anti-Alzheimer's disease. The results of the TOMMORROW trial will be presented at future scientific conferences and will continue to work to share key data with the scientific community."
Ann Saunders, CEO of Zinfandel, said, “The Phase III trial will provide valuable clinical data that will provide valuable insights into the earliest stages of Alzheimer's and help alleviate the burden of disease on patients. â€
Despite the failure of this trial, Takeda said that he will continue to work on the treatment of AD. Earlier this year, it signed a cooperation agreement with Denali Pharmaceuticals on three Alzheimer's disease projects, which promised to be realized within the year. If regulatory and clinical milestones are taken into account, the deal can be worth up to $1 billion. The two companies did not disclose detailed information about the three programs, but they said that ATV technology will strengthen the blood-brain barrier penetration of Alzheimer's patients.
Alzheimer's disease and other forms of dementia are a growing health care issue. In the United States, Alzheimer's disease is the sixth leading cause of death and the fifth leading cause of death among people over 65 years of age. It is estimated that by 2050, the number of patients worldwide will reach 113.5 million.
AD treatment is clearly a difficult problem, and many companies have announced that they have terminated their R&D plans due to trial failure. In February 2017, Merck announced the discontinuation of Verubecestat in Phase 2/3 clinical trials for patients with mild to moderate Alzheimer's disease. In September 2017, Axovant's Phase III clinical trial in patients with Alzheimer's disease showed no significant difference from placebo. Earlier this month, Pfizer said it would abandon its work on developing Alzheimer's and Parkinson's disease, and the list of similar losers is still long.
Just this week, Eli Lilly released the failed EXPEDITION3 trial data, which is expected to demonstrate the breakdown of beta-amyloid plaques in the brain to slow the progression of Alzheimer's disease. However, the final test results did not verify the results of the early Solanezumab trial. However, Eli Lilly responded that it will continue to develop treatments for Alzheimer's disease. It currently has eight different experimental drugs, including Lanabecestat, AstraZeneca-authorized BACE drugs, and the failed Solanezumab. (Sina Pharmaceutical Compilation / Fan Dongdong)
Article, image reference source: Takeda Becomes the Latest to Notch an Alzheimer's Failure Under Its Belt
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