The US pharmaceutical company Eli Lilly published just these days the results of the phase three clinical trial for the donanemaba monoclonal antibody that appears to have good effects in reducing the presence of so-called amyloid plaquesone of the most accredited causes of the progression and perhaps of the onset ofAlzheimer. Unfortunately, just like lecanemab, another monoclonal antibody being studied for the treatment of people with this neurodegenerative disease, donanemab can also cause side effects not to be underestimated, as Eli Lilly herself acknowledges.
The potential benefits
“We are encouraged by the potential clinical benefits that donanemab can offer, although, like many effective treatments for debilitating and fatal diseases, there are associated risks that can be serious and life-threatening,” said Mark Mintun, group vice president of Neuroscience Research & Development at Lilly and president of Avid Radiopharmaceuticals. “We note – he continues – that these results suggest that people in the early stage of the disease may be the most responsive to therapies that target theamyloid”. The formation of amyloid plaques is due to the accumulation of a proteincalled beta-amyloid, which is no longer functional, i.e. which has lost some of its biochemical characteristics and which consequently forms aggregated and precipitated within neuronal cells. According to data released by the pharmaceutical company, treatment with the monoclonal antibody would have a lot reduced the presence of these formations.
Aducanumab, the first drug against Alzheimer’s in the US, confuses doctors and patients
The study involved a total of about 1700 patients with initial signs of cognitive decline and other markers related to the development of the disease Alzheimer. According to data reported by Eli Lilly, the 47% of participants treated with donanemab did not experience clinical progression during the year of treatmentagainst the 29% of patients treated with placebo. “We are extremely pleased with that donanemab yielded positive clinical results, with convincing statistical significance, for people with Alzheimer’s disease in this study,” added Daniel Skovronsky, chief scientist and chief physician at Lilly and president of Lilly Research Laboratories. “It’s about the first Phase 3 study of an investigational drug for Alzheimer’s disease that he obtained a 35% slowing of clinical and functional decline”.
The side effects
Unfortunately, however, as we said, even the side effects were not lacking. Some patients have developed a condition said Aria (amyloid-related imaging abnormalities)which consists in the occurrence of temporary swelling in some areas of the brain (Air-E) or in microemorragie (Aria-H), sometimes seen following treatment with this class of monoclonal antibodies. Twenty-four percent of donanemab-treated participants developed Aria-E, while 31.4 percent experienced symptoms related to the other condition, Aria-H, versus 13.6 percent of placebo-treated patients. According to the pharmaceutical company, in most cases these were symptoms rated as mild or moderatewhile a 1,6% has developed a severe symptoms. Three patients died during the trial from causes possibly attributable to Aria.
Finally, as underlined by a news of Scienceconsidering the parameter defined as Clinical Dementia Rating-Sum of Boxes (Cdr-Sb), the absolute difference between the antibody-treated group and the placebo-treated group would be just under 0.7. In the past, a study on this issue he had concluded that it was necessary at least one full point of difference on this scale in order to observe a clinically relevant difference in disease progression. In conclusion, it is important to recognize progress especially in understanding what the causes that trigger the disease and which seem to be confirmed by the studies carried out on this class of monoclonal antibodies. At the same time, according to experts, it will be necessary to wait for the publication of further data to assess on which side the balance is tipped, between risks and benefits.
Via Wired.it
Believe image: Franco’s dish/Unsplash