- Alzheimer's drug from Eli Lilly And Co LLY failed to slow cognitive decline over about 4.5 years of treatment in individuals with amyloid plaque but no clinical symptoms.
- The experimental drug, solanezumab, was designed to target only soluble forms of amyloid beta, a toxic protein that accumulates in the brains of people with Alzheimer's.
- The treatment did not clear plaque or halt the accumulation of amyloid in participants treated with the drug in the Anti-Amyloid Treatment in Asymptomatic Alzheimer's disease (A4) Study.
- Solanezumab binds only to soluble amyloid-beta protein and was not expected to remove deposited amyloid plaques significantly.
- "Therefore, the A4 Study concludes our clinical development of solanezumab and indicates that targeting soluble amyloid beta through this mechanism is not effective in this population," said John Sims, head of medical, global brand development for Eli Lilly.
- Launched in 2013, the A4 study enrolled over 1,100 individuals between 65 and 85 years of age who had PET-imaging evidence of amyloid plaque accumulation in the brain and had no clinical impairment.
- The study did not meet its primary goal of slowing cognitive decline, and placebo patients did better on secondary goals, such as changes in daily activity.
- 36.1% of trial participants developed symptomatic Alzheimer's, and progression rates were similar for both the treatment and placebo groups, Lilly said.
- Amyloid continued accumulating over time in both the placebo (65.9 Centiloid baseline, 17.5 Centiloid increase) and solanezumab (66.2 Centiloid baseline, 12.1 Centiloid increase) groups.
- Donanemab and remternetug, other Lilly investigational antibodies currently being developed in Phase 3. They specifically target deposited amyloid plaque and have been shown to lead to plaque clearance in treated patients.
- Price Action: LLY shares are down 1.17 at $308.88 premarket on the last check Thursday.
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