Eli Lilly & Co. said it will end development of an experimental Alzheimer’s treatment that is similar to failed drug candidate solanezumab, though the U.S. company is exploring other potential medicines for the memory-robbing disease.
Lilly remains committed to the rest of its Alzheimer’s portfolio, which now consists of eight candidates, company officials said during an earnings guidance call with Wall Street analysts. These experimental drugs target amyloid beta proteins, whose accumulation in the brain is thought to play a central role in the disease, but they do so in a different way compared to solanezumab, Lilly senior vice president and incoming CEO David Ricks said.
Two of the Alzheimer's candidates inhibit the oral beta secretase cleaving enzyme, or BACE, that is associated with the development of amyloid beta proteins. One of the BACE inhibitors, which received fast-track designation from the FDA to accelerate its development program, is in the third and final stage of human testing, and the other is in the second stage of human testing.
In addition, Lilly just entered into an agreement with AstraZeneca PLC to co-develop an Alzheimer's antibody treatment known as MEDI1814. These candidates "could produce more significant clinical benefit than solanezumab," Ricks said.
Meanwhile, another early-stage candidate targets the amyloid deposits in the brain, as opposed to amyloid in the blood, as is the case with solanezumab and the BACE inhibitors, according to a company presentation to analysts.
The failed solanezumab trial is informing Lilly's approach to the development of its Alzheimer's pipeline, company executives said.
"We would be looking to raise the threshold of effect, either on biomarkers or some clinical measure in earlier studies before escalating" into a late-stage trial, Ricks said. "I think that's clearly a takeaway here."
But Senior Vice President Enrique Conterno said that trial is not very instructive about which goals to use in the future because of its small effect.
"We're going to need to look for medicines that are more impactful either alone or in combination to make a difference in this tough disease," Ricks said.
Citing interviews with research physicians, Leerink equity analyst Geoffrey Porges wrote in a Dec. 15 research note that the solanezumab trial does not confirm or deny the "amyloid hypothesis" that the proteins play a central role in the disease. He said the physicians expect investment in Alzheimer's research and development to continue across the industry.