Dementia drug dawn
March 24, 2016 Source: HC Pharmaceutical Industry Network
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)];Alzheimer's disease is characterized by cognitive decline and the accumulation of amyloid in the brain.
After years of disappointment, clinical trial results released recently showed that antibody therapy may bring small improvements to patients with Alzheimer's disease (also known as Alzheimer's disease).
Both drugs, Solanezumab from Eli Lilly and aducanumab from Baijian, both target beta-amyloid accumulated in the brains of Alzheimer's patients. Considering that antibody drugs against amyloid failed in every trial against Alzheimer's disease, many researchers questioned whether the latest results could stand the test. The details of the two outcomes were presented at the International Conference of the Alzheimer's Association in Washington, DC.
Eli Lilly, based in Indianapolis, Indiana, said that in a trial involving 440 participants, solanezumab appeared to slow cognitive decline in patients with mild Alzheimer's disease by about 30%. . At 18 months, the loss of mental acuity in these patients was equivalent to the degree of deterioration experienced by participants with similar levels of Alzheimer's disease in the placebo group in only 12 months.
Lilly's company was lucky to win this time. In 2012, the company reported no difference between patients taking solanezumab for 18 consecutive months and patients taking placebo. However, when the company reanalyzed the trial, it found a slight improvement in the participants with mild symptoms at the start of the trial. Lilly continued the six-month trial and began taking solanezumab to 440 control members who were more severe at this time.
Lilly showed at the meeting that a group that took the late start of the drug slowed their cognitive decline to match the rate of decline in the 440 patients who were treated throughout the study. This suggests that the drug targets the root cause of Alzheimer's disease, not just its symptoms.
The results of the Washington-based Baijian Company showed that taking a moderate dose of the drug aducanumab reduced amyloid in 23 patients, but the clinical benefit was not statistically significant. In March of this year, the company reported that 27 patients who took high-dose drugs for one year in a row showed significantly less cognitive decline and had less amyloid aggregation in their brains than those who received placebo. .
Both outcomes support the "amyloid hypothesis": the accumulation of amyloid in the brain is a cause of Alzheimer's disease and therefore unaffected, while removing them can prevent disease. "We are moving slowly in the right direction." Samuel Gandy, a neurobiologist at Mount Sinai School of Medicine in New York, said that there are so many gratifying results because things have been pessimistic for so long.
Solanezumab failed in some of the previous experiments, and the pharmaceutical companies Pfizer and Johnson & Johnson stopped developing their antibody drug bapinezumab in 2012 after failing in 2,400 trials. In December last year, Roche Pharmaceuticals of Switzerland suspended a trial of 3,000 people against its antibody drug candidate, gantenerumab, although the results of this demonstration showed that the highest dose of the drug had entered the brain at least and reduced the number of patients with faster progression. The amount of amyloid in the medium.
Given the relatively small size of clinical trials, experts welcomed these results with restrained excitement. However, Eli Siemers, an Alzheimer's researcher at Eli Lilly and Company, is very optimistic. "The effect of solanezumab is very good, which surprised me." He said that the prospect of delaying the deterioration of the disease is very good.
In 2013, Lilly launched a larger phase 3 trial of solanezumab, recruiting 2,100 patients with mild symptoms and amyloid accumulation in the brain. The company will conclude the study in 2016. In December last year, Baijian said it would launch a three-phase trial involving 2,700 participants for 18 months.
University of Southern California Alzheimer's disease researcher Lon Schneider questioned the decision to launch a large trial before the drug and the "amyloid hypothesis" were well validated. It is noted that behavioral interventions such as diet and exercise have been shown to be similar to any drug in terms of mitigation of Alzheimer's disease. “Why are there so many antibodies, and none of them have proven effective so far?â€
However, not everyone agrees with this view. "It's time to move forward boldly," said Randall Bateman, a neuroscientist at the University of Washington. "I think that from the perspective of human suffering, the cost of postponing is much more expensive than advancing and taking the initiative."
Bateman is leading a trial in which Lilly's solanezumab and Roche's ganetererumab are tested in 160 people aged 18-80 who have a genetic risk of Alzheimer's disease but no symptoms. This is one of many attempts to determine whether the disease can be prevented by destroying amyloid before the brain is damaged. This brain damage can occur in decades, and many Alzheimer's researchers suspect that antibody trials have failed because they are too late to treat patients.
This hypothesis is evidenced by the discovery of Lilly, that is, only patients with mild symptoms can benefit from solanezumab. Eric Reiman, executive director of the Baner Alzheimer's Institute in Phoenix, Arizona, said that the latest results have also shown for the first time in humans that slowing amyloid accumulation can delay cognitive decline.
This is important because the US Food and Drug Administration has stated that drugs that block amyloid accumulation will not be approved without sufficient evidence of clinical benefit. Reiman, who is leading a Roche antibody drug crenezumab trial that has failed in large trials, says that if a pharmaceutical company can justify the cause and effect of amyloid accumulation and worsening Alzheimer's disease, all companies Will benefit.
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