Today (3 May 2023) the pharmaceutical company Eli Lilly has announced positive results from its phase 3 clinical trial of donanemab for the treatment of Alzheimer's disease. Lilly reports that the drug slowed cognitive decline by 35% compared to a placebo.
The news follows promising results from Eisai and Biogen, who reported in Autumn last year that their anti-amyloid therapy lecanemab had shown a slowing of cognitive decline by 27%, and was granted accelerated approval by the FDA in January.
This is extremely exciting news for the Alzheimer’s research community and the millions of people affected by the condition worldwide. It is very encouraging to see a second anti-amyloid drug showing success in trials, especially using a completely independent approach. Prof Bart De Strooper, Director of the UK DRI
The donanemab trial, known as TRAILBLAZER-ALZ 2, included 1,182 people with early symptomatic Alzheimer's disease. The full results are due to be presented at the Alzheimer’s Association International Conference in July, and the company plans to seek approval from the US Food and Drug Administration (FDA) in the coming months.
Here, UK DRI researchers comment on the news.
Prof Bart De Strooper, Director of the UK DRI, commented:
“This is extremely exciting news for the Alzheimer’s research community and the millions of people affected by the condition worldwide. It is very encouraging to see a second anti-amyloid drug showing success in trials, especially using a completely independent approach.
We will need to wait for the full results to be presented in the summer to assess the data in more detail, but the effects are convincing and these initial results confirm that amyloid beta is a good target, and that treating people earlier is going to give better results. This reinforces the need for effective diagnostics alongside these emerging treatments.
Interestingly, the results suggest treatment is only required until the plaques have been cleared from the brain, which means this will be cheaper, safer and more practical than continued treatment with a drug such as lecanemab.”
Prof John Hardy, Group Leader at the UK DRI at UCL, said:
“It is great news to have a success with a second anti-amyloid Alzheimer drug. This should dispel any lingering doubts about this approach. Having two drugs is great for competition.
There is much work still to do if these drugs are approved as they should be. From a practical perspective we need to organise how to get these drugs into patients safely, and from a research perspective we need to understand why they slow disease but do not – yet at least - seem to stop progression.”
Prof Tara Spires-Jones, Group Leader at the UK DRI at Edinburgh, added:
"This press release from Eli Lilly and Company sounds very promising. While the full data have not been shared with the scientific community, meaning we can’t yet judge how robust they are, the company reports that their drug donanemab slowed decline in people with early Alzheimer’s disease. The effects are very similar to two other recently approved drugs that act on the same target, showing remarkable consistency in the ability to slow cognitive decline in early Alzheimer’s disease by around 30-35% with drugs that lower amyloid levels.
It is important to note that there were rare serious side effects of the treatment with brain swelling and small strokes that seem to have contributed to the death of 3 of the participants in the trial. Regulators will have to decide whether the benefits of treatment outweigh these risks. This positive result and the two recent similar successful trials are very welcome good news after decades of clinical trial failures. This is an excellent example of how fundamental neuroscience research into the brain changes that cause Alzheimer’s can be translated into effective treatments."
Prof Nick Fox, Group Leader at the UK DRI at UCL, said:
“Although we only have a press release, this announcement is consistent with earlier phase 2 results - and confirms that we are in a new era of disease modification for Alzheimer’s disease. Dramatic and rapid amyloid removal was accompanied by slowing of cognitive decline. The challenge now is to be able to deliver these therapies in already stretched health care systems and to do so safely.”
Dr Marc Aurel Busche, Group Leader at the UK DRI at UCL, said:
“This clinical trial is a real breakthrough, demonstrating a remarkable 35% slowing of cognitive decline in Alzheimer's patients with high amyloid-beta but low tau burden. I believe this therapy has the potential to significantly improve patients' and families' lives today. Notably, the beneficial effect was smaller in those with high tau levels, suggesting a potential interaction between these pathogenic proteins. Looking ahead, I anticipate that concurrently targeting amyloid-beta and tau could lead to even better patient outcomes, making this a crucial focus for future research and the next generation of clinical trials.”
For more details on the announcement and next steps, please see the official press release from Eli Lilly.
Article published: 3 May 2023
Banner image: Shutterstock/Gorodenkoff
