Lilly sends Alzheimer ’s drug developers higher after trial data
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Eli Lilly (NYSE:LLY) added ~7% to reach a new 52-week high Wednesday after the company reported early Phase 3 data for its anti-amyloid agent donanemab in Alzheimer's disease, sparking sharp gains among rival drug developers.
Notable gainers include Alzheimer's drug developers Prothena (PRTA), Acumen Pharmaceuticals (ABOS), Annovis Bio (ANVS), and Anavex Life Sciences (AVXL).
Meanwhile, Biogen (BIIB), which recently won FDA's accelerated approval for its Alzheimer's therapy Leqembi (lecanemab), developed in partnership with Eisai (OTCPK:ESALF) (OTCPK:ESAIY), is trading flat.
Announcing topline data from its TRAILBLAZER-ALZ 2 trial in the pre-market, LLY said that donanemab slowed Alzheimer's clinical decline by 35% compared to placebo at 18 months, while 47% of patients on the drug had no clinical progression at year one compared to 29% on placebo.
"This is the first Phase 3 trial of any investigational medicine for Alzheimer's disease to deliver 35% slowing of clinical and functional decline," Daniel Skovronsky, Lilly's chief scientific and medical officer, remarked.
"Donanemab Succeeds, But Safety Remains a Concern," SVB Securities analyst David Risinger wrote in a research note as the company indicated 1.6% of trial participants showed amyloid-related brain swelling identified as amyloid-related imaging abnormalities (ARIA).
While most ARIA cases were mild to moderate, two deaths in the study were attributed to the condition, and another patient died due to a severe ARIA event.
However, Dr. Erik Musiek, a Washington University neurologist at Barnes-Jewish Hospital, found the efficacy of donanemab at the same level or better than lecanemab, Biogen (BIIB), and Eisai's (OTCPK:ESAIY) anti-amyloid agent.
"The evidence is really starting to build up that these drugs do work," Reuters quoted Musiek as saying. "It really does suggest that you need to remove these plaques early, before the tau really gets going," he added, referring to a protein linked to disease progression and brain cell death.