Alector Inc. shares plummeted over 60% on Monday after its lead drug candidate for early-stage Alzheimer’s disease failed to demonstrate a statistically notable slowing of cognitive decline in a late-stage clinical trial. The disappointing results represent a major setback for the biotechnology company and a potential blow to the field of Alzheimer’s research, wich has seen numerous high-profile drug failures in recent years.
The Phase 3 trial, known as Illuminate, evaluated Alector’s drug AL003 in 800 participants with mild cognitive impairment due to Alzheimer’s disease. While the drug was found to be safe and well-tolerated, it did not meet its primary endpoint of improving cognitive function compared to a placebo group over 18 months.The failure underscores the immense challenge of developing effective treatments for Alzheimer’s, a devastating neurodegenerative disease affecting over 6.7 million Americans, and highlights the urgent need for new therapeutic approaches.
Alector initiated a separate,ongoing trial called Transcend,evaluating AL003 in individuals with earlier stages of Alzheimer’s disease,and plans to continue that study.Top-line data from Transcend is expected in the first half of 2025. The company stated it is evaluating the Illuminate data to understand potential reasons for the outcome and will present the full results at a future medical conference.
“We are deeply disappointed by these results,” said Dr. Arnon Rosenthal, CEO of Alector, in a press release. “We remain committed to our mission of developing innovative therapies for neurodegenerative diseases, and we will continue to advance our pipeline of programs.”
The stock closed at $8.48, down 63.8% from its Friday close of $18.62. The company’s market capitalization has fallen to approximately $450 million.
alzheimer’s disease is characterized by the accumulation of amyloid plaques and tau tangles in the brain, leading to neuronal damage and cognitive decline. Despite decades of research,there are currently limited treatment options available,primarily focused on managing symptoms rather than slowing or halting disease progression. Recent approvals of drugs like Leqembi and Aduhelm, which target amyloid plaques, have offered a glimmer of hope, but thier clinical benefits have been modest and accompanied by safety concerns.
