Eli Lilly and Co has shared full findings of its phase 3 clinical study of donanemab at the Alzheimer’s Association International Conference in Amsterdam which shows that the newly developed drug can modestly slow patients’ inevitable worsening.
To put a number, the report claims that the drug can slow down the process 35% or by 4-7 months.
Eli Lilly and Co. has said it applied for full US approval of its Alzheimer’s disease drug. If approved this will be the second effective drug to combat the mind-robbing disease, after Japanese drugmaker Eisai developed Leqembi.
More than 1,700 patients with early-stage Alzheimer’s disease or mild cognitive impairment received Lilly’s drug or a placebo in the 18-month trial. Donanemab slowed progression of cognitive and functional decline by 22% on one composite scale and 29% on a similar measure when compared to a placebo.
Lilly announced in May that donanemab appeared to work, but on Monday the full results of a study of 1,700 patients was published by the Journal of the American Medical Association and presented at the Alzheimer’s conference.
Both donanemab and Leqembi are lab-made antibodies, administered by IV, that target one Alzheimer’s culprit, sticky amyloid buildup in the brain. And both drugs come with a serious safety concern — brain swelling or bleeding that in the Lilly study was linked to three deaths.
Scientists say while these drugs may mark a new era in Alzheimer’s therapy, huge questions remain about which patients should try them and how much benefit they’ll really notice.
Lilly’s study enrolled people ages 60 to 85 who were in early stages of Alzheimer’s. Half received once-a-month infusions of donanemab and half dummy infusions for 18 months.
The study had a few twists. Patients were switched to dummy infusions if enough amyloid cleared out — something that happened to about half within a year. And because amyloid alone doesn’t cause Alzheimer’s, researchers also tracked levels of another culprit in the brain — abnormal tau. More tau signals more advanced disease.
The results: Both groups declined during the 18-month study but overall those given donanemab worsened about 22% more slowly. Some patients fared better — those with low to medium tau levels saw a 35% slower decline, reflecting that the drug appears to work better in earlier stages of the disease.
How much difference does that make? It means donanemab slowed patients’ worsening by about four to seven months, the JAMA report concluded.
Another way of measuring: Among the donanemab recipients with lower tau levels, 47% were considered stable a year into the study compared with 29% of those who got the dummy version.
The main safety concern is brain swelling or bleeding, which often causes no symptoms but sometimes can be serious, even fatal. About a quarter of donanemab recipients showed evidence of that swelling, and about 20% had microbleeds.
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Updated: 17 Jul 2023, 09:07 PM IST