The challenging field of Alzheimer's has claimed another drug development program. Eli Lilly (NYSE: LLY) said today that it's halting all Phase III trials of semagacestat after preliminary results showed the drug did not slow disease progression and was associated with worsening of clinical measures of cognition and the ability to perform activities of daily living.
After reviewing preliminary results from 2,600 patients enrolled in two Phase III trials, researchers found that patients treated with semagacestat worsened to a statistically significantly greater degree than those receiving placebo. The drug was also associated with an increased risk of skin cancer. Lilly plans to continue collecting safety data from the study, including cognitive scores, for at least six months. The company says it will publish results from the studies for the benefit of future Alzheimer's research.
Lilly has invested heavily in semagacestat and another Alzheimer's candidate called solanezumab. The drugs target beta amyloid--plaque that accumulates in the brain--along different pathways. Researchers have recruited more than 1,000 patients for each of a series of late-stage trials. The company notes that its decision to axe the semagacestat program doesn't impact ongoing clinical trials of solanezumab or two other Alzheimer's compounds in earlier stages of development.
- here's Eli Lilly's release