During Eli Lilly's quarterly results presentation Wednesday, CEO David Ricks indicated that the company does not intend to delve back and re-analyse data from the failed EXPEDITION3 trial of the investigational Alzheimer's disease drug solanezumab, Bloomberg reported.
His remarks follow the announcement this week that Biogen would be seeking US approval of aducanumab after a new analysis of two Phase III trials, which had been shelved earlier this year for being unlikely to meet their primary endpoints, suggested the experimental anti-amyloid beta antibody might benefit patients after all, but at a higher dose.
Ricks said Biogen's reversal was a "a surprising set of events." However, he warned that revisiting EXPEDITION3 could raise doubts about Eli Lilly's research methods, saying "you have to call your shot and if you hit it, you have confidence that medicine is working. It's important that people, patients have confidence in your studies." Solanezumab showed a reduction in cognitive decline in the EXPEDITION3 trial, but it was not significant, "so we moved on," Ricks said.
Nevertheless, the executive acknowledged that "it's good news when someone else gets a glimmer of hope. This is a tough space." He suggested that if Biogen's new analysis that a higher dose of aducanumab improved patient outcomes stands up to scrutiny, it "would be very encouraging" for Eli Lilly, which is evaluating solanezumab at a four-times higher dose in elderly people who may be at risk for Alzheimer's disease. Results from that trial are expected in mid-2022.
For related analysis, see ViewPoints: Biogen's aducanumab about-face – stunning resurrection or Hail Mary?
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