Home » Alzheimer’s, good results of a new molecule in clinical tests

Alzheimer’s, good results of a new molecule in clinical tests

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GOOD results from a study on patients with Alzheimer of a new molecule – an antibody – to trap the ‘toxic plaques’ of beta-amyloid substance in the brain believed to be the cause of the disease: the antibody, called Donanemab, is able to slow the decline of mental (cognitive) abilities of patients in the early stages of the disease.

Released in the magazine New England Journal of Medicine and simultaneously presented on the occasion of the 15th International Conference on Alzheimer’s and Parkinson’s Diseases held virtually in March, are the most promising results ever obtained so far with an experimental drug for a disease that affects more than 35 million patients worldwide, destined to triple by 2050, and which still remains orphaned of care.

“This experimental drug has already shown in phase 2 of clinical trials the ability to modify the clinical picture of the disease, slowing down the cognitive decline of treated patients”, he explains in a comment. Michele Vendruscolo of the University of Cambridge (GB). “If even the phase 3 clinical trials give positive results – he adds – donanemab could be approved for the treatment ofAlzheimer; the conclusion of the trials will be in the middle of 2023 ”, specifies the expert.

The road to treating the most widespread form of dementia (Alzheimer’s represents 70% of all cases of dementia) is studded with failures: over 400 clinical trials (even at an advanced stage) concluded with nothing, tests on different molecules, almost all aimed at eliminating the deposits of beta-amyloid substance that is found accumulated in excess in the brains of patients. Over the years, antibodies tested for this purpose have proven to be able to remove ‘waste’ in the brain, but this result is almost never matched by an improvement in the cognitive functions of patients treated with the molecules.

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To date, the substance which is looked at with the most interest is the anti-amyloid monoclonal antibody ‘Aducanumab‘, although he has a troubled history of suspended and then resumed clinical trials. According to recent analyzes, the antibody appears to be able to delay cognitive decline at least in some types of patients. There Biogen that produces it has requested theauthorization to use the drug both in the USA and in Europe but the most likely prospect is that the Food and Drug Administration – the US drug regulatory body – will give only one in Juneconditional approval‘to the drug, or will approve it with a request for an additional clinical trial to dispel all doubts about him.

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Another promising substance is “BAN2401”, He explains Vendruscolo, in turn an antibody that has so far been shown to substantially reduce the formation of amyloid plaques and is currently in phase 3 clinical trials due to end in 2024. If successful, these clinical trials will provide a solid basis for the approval of BAN2401 as a treatment forAlzheimer.

Also Donanemab, however, is about to place itself in the front row among the potentially most promising drugs and also to surpass them: tested on 257 patients, of which 131 have taken the drug once every 4 weeks for 72 weeks and the remaining a placebo substance, the antibody not only was it capable of clearing the brains of patients (observed with positron emission tomography – PET) of beta-amyloid plaques, but it also slowed the cognitive decline of patients by 32%. It means that after the dosing period the patients who took the antibody got worse less than the patients who took placebo; more precisely, he explains Vendruscolo, the group that took the drug worsened by nearly 7 points on the rating scale used, compared with a worsening over the same time frame of more than 10 points in the placebo group.

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According to the study’s lead author, Mark Mintun di Eli Lilly & Company, in patients with Alzheimer at an early stage, donanemab has obtained good results in delaying the decline of cognition and the ability to carry out daily life actions, although larger and longer trials are needed to study its efficacy and safety and verify if it can also improve functions cognitive as well as slowing their decline.

“With these antibodies with promising results in clinical trials, 2021 seems to be a turning point for theAlzheimer, the possibility of finally having therapies capable of modifying the course of the disease is becoming more and more concrete ”, concludes Vendruscolo.

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