Lights and shadows of donanemab, Lilly’s new Alzheimer’s drug

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Lilly’s Alzheimer’s drug Donanemab promises to slow the progression of symptoms such as cognitive and functional decline in patients with early-stage Alzheimer’s disease by 35%, but hides side effects.

Lights and shadows of donanemab, Lilly’s new Alzheimer’s drug

In the race to find new drugs to combat Alzheimer’s, a new player has just appeared. This is donanemab, an experimental drug against Alzheimer’s that acts against the amyloid protein that causes this type of dementia and has obtained promising results in a phase 3 clinical trial –not yet published in any scientific journal– in which 1,736 have participated. people between the ages of 60 and 85. In an analysis of nearly 1,200 patients who were in the early stages of the disease and had brain amyloid deposits and intermediate levels of TAU, treatment with donanemab slowed symptom progression by 35% over 18 months compared with with the placebo.

Pharmaceutical company Eli Lilly has developed this drug and has reported the results of the trial in a press release highlighting that it significantly reduces the cognitive and functional decline caused by Alzheimer’s, which have been measured based on the ability of patients to carry out perform everyday tasks such as managing your money, driving, participating in leisure activities, and discussing current affairs on a standardized rate known as the Integrated Alzheimer’s Disease Rating Scale (iADRS).

Donanemab is a monoclonal antibody with a mechanism of action similar to that of other drugs that have recently been developed for the treatment of Alzheimer’s, such as lecanemab from Biogen and Eisai, which has been shown to reduce the rate of cognitive decline by 27% and was approved in the United States United in January, or aducanumab (Aduhelm), approved by the US FDA in 2021, a highly controversial decision, as it causes serious side effects and its clinical efficacy is doubtful.

Amyloid beta and tau proteins accumulate in tangles and plaques in the brain – toxic aggregates – causing the death of neurons that leads to the loss of memory and cognitive abilities associated with Alzheimer’s. The buildup of these plaques can make it difficult for brain cells to communicate and cause inflammation of the brain. Donanemab is an antibody therapy directed against beta amyloid with the aim of stopping or delaying the progression of Alzheimer’s symptoms.

“The results show the ability to slow down cognitive decline in early Alzheimer’s disease by around 30-35% with drugs that reduce amyloid levels”

“We are very pleased that donanemab has yielded positive clinical results with compelling statistical significance for people with Alzheimer’s disease in this trial,” Daniel Skovronsky, Lilly’s chief scientific and medical officer, said in a statement.

Possible risks and side effects of donanemab for Alzheimer’s

Mark Mintun, a Lilly senior executive in neuroscience research and development, added that “like many effective treatments for debilitating and fatal diseases, there are associated risks that can be serious and life-threatening.” In fact, important side effects have been observed, such as temporary inflammation in some areas of the brain, which affected almost a quarter of the treated patients, and microbleeds that occurred in 31% of the treated patients and 14% of the treated patients. patients given placebo. In addition, the deaths of two participants were attributed to side effects, and another may also have died as a result of the treatment.

Tara Spires-Jones, Deputy Director of the Center for Discovery Brain Sciences at the University of Edinburgh, Group Leader of the UK Dementia Research Institute and President of the British Association for Neuroscience, praised the results published by Lilly in a statement to SMC Spain: “The effects are very similar to those of other recent trials with drugs that act on the same target, and show remarkable consistency in the ability to slow down cognitive decline in early Alzheimer’s disease by around 30-35%. with drugs that reduce amyloid levels.

The expert, however, is concerned about the adverse effects that have been detected: “It is important to note that the treatment had infrequent serious side effects, such as brain swelling and small strokes that appear to have contributed to the death of three of the patients.” trial participants. Regulators will have to decide whether the benefits of treatment outweigh these risks.”

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