Lilly posts Phase 3 data to compare its Alzheimer’s drug vs. Biogen’s
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Eli Lilly (NYSE:LLY) shared data from a Phase 3 trial for its Alzheimer's disease donanemab, comparing its performance against Aduhelm, an FDA-approved Alzheimer's therapy developed by Biogen (NASDAQ:BIIB) and Eisai (OTCPK:ESALF) (OTCPK:ESALY)
The company said that per data from the 6-month primary outcome analysis in the ongoing TRAILBLAZER-ALZ 4 study, donanemab met all primary and secondary endpoints.
In terms of co-primary outcomes, 37.9% of donanemab-treated participants (25 of 66) achieved brain amyloid plaque clearance, a measure the FDA considered in granting the accelerated approval for Aduhelm in June 2021.
In comparison, 1.6% of Aduhelm-treated patients (1 of 64) achieved brain amyloid plaque clearance at six months.
The company said that donanemab also reduced brain amyloid levels vs. baseline by 65.2%, achieving a key secondary endpoint. Meanwhile, in patients treated with Aduhelm, the decline of brain amyloid levels vs. baseline stood at 17.0%.
In both groups, the most common treatment-emergent adverse event was amyloid-related imaging abnormalities (ARIA), a key concern related to drugs such as Aduhelm and donanemab that target beta-amyloid.
ARIA in donanemab and Aduhelm-treated patients stood at 25.4% and 26.1%, with 2.8% and 4.3% cases being symptomatic, respectively.
TRAILBLAZER-ALZ 4 is one of five studies that Lilly (LLY) employs to support donanemab development against Alzheimer's, and the open-label trial that involves 148 patients aged 50 to 85 with early symptomatic AD will also have 12-month and 18-month secondary analyses.
In January 2021, Lilly (LLY) said its Phase 2 TRAILBLAZER-ALZ study for donanemab met the main goal.
Meanwhile, Biogen (BIIB) and Eisai (OTCPK:ESALF) (OTCPK:ESALY) have advanced their research efforts against Alzheimer's while demand for Aduhelm dropped amid concerns over its efficacy and safety. Early this week, the companies shared full data from a Phase 3 study for a new Alzheimer's candidate called lecanemab.