- Ahead of expectations, Eli Lilly & Co. revealed early Nov. 23 that the EXPEDITION 3 trial, testing solanezumab in 2,100 patients with mild dementia due to Alzheimer's disease, failed to meet its primary endpoint.
- Solanezumab patients did not experience a statistically significant slowing in cognitive decline compared with placebo (p=0.095), as measured by the Alzheimer's Disease Assessment Scale-Cognitive subscale.
- Lilly said it will not pursue a regulatory submission of solanezumab, but has not yet determined the next steps for the program.
The final nail has been put in the coffin of Lilly's Alzheimer's disease hopes, now that its third Phase 3 EXPEDITION trial has failed. Across its late-stage studies, Lilly tested the drug in more than 4,000 patients and failed to outperform a placebo in any of the trials.
The company opted to pursue the EXPEDITION 3 trial despite previous failures in hopes that testing the drug in an earlier patient population that was less sick would show different results.
Lilly noted on a Nov. 23 call with reporters that some of the results "directionally favored" solanezumab, but did not go into detail on what that meant.
"The success of Lilly as a whole does not rest on the fate of one compound," Lilly's incoming-CEO and President of its Bio-Medicines business Dave Ricks on the call.
Ricks took a somber tone when declaring the company's disappointment about the results and noted that there are six other Alzheimer's disease treatments in Lilly's pipeline that are all based on different mechanisms of action than solanezumab. "We remain undeterred in our commitment to Alzheimer's disease," he added, noting Lilly has spent more than $3 billion investigating Alzheimer's therapies over the last 27 years.
Lilly will present the full trial results at the Clinical Trials on Alzheimer’s Disease (CTAD) meeting on Dec. 9. The company expects to take a charge of $150 million, or 9 cents per share, in the fourth quarter related to the failure. Lilly said it will update its guidance on Dec. 15.
Solanezumab was based on the theory that a buildup of amyloid-beta plaque in a patient's brain has an impact on cognition and leads to a disease. That hypothesis has been the groundwork for much of the development in Alzheimer's disease. Yet, with each failure, critics declare the theory to be wrong.
"We believe that failure of solanezumab should not discredit the amyloid hypothesis entirely, since the varying structures, targets and dosing of the different Abeta-antibodies could potentially mean that where one fails, another may still succeed," wrote Jefferies analyst Peter Welford in a same day note to investors.
Lilly's stock took a hit on the news, dropping nearly 12% to trade near $67 per share. Meanwhile, other companies in the space also dropped on the news. Biogen was down about 5% in mid-morning trading, while Axovant Sciences, which is developing an AD drug that works differently, was down only 2%.