Lilly moves Alzheimer’s drug into late-stage testing

Alzheimer’s disease is a stubborn malady. Not only does it cripple a person’s ability to think and remember, it has baffled researchers for years on how to attack or treat it, causing numerous expensive setbacks.

But Eli Lilly and partner AstraZeneca say they have some good news on a new potential treatment.

It’s an oral drug in development, called AZD3293, that the companies say has shown success in early-phase trials to reduce levels of amyloid beta.
 That’s the protein believed to be responsible for creating a sticky plaque in the brain that interferes with thinking and remembering.

The two companies say they would mill the drug into late-stage clinical trials without modification on the recommendation of an independent data monitoring committee, following a positive interim safety analysis.

The new clinical trial, named Daybreak, will study the safety and effectiveness of the drug in people with mild Alzheimer’s disease. It will begin enrolling participants in the third quarter.

That triggered a milestone payment of $100 million from Lilly to AstraZeneca. The companies formed an alliance in 2014 for the development and commercialization of the drug.

Under the agreement, Lilly will lead clinical development, while AstraZeneca will be responsible for manufacturing. The two company will share all costs and revenues.

Alzheimer’s disease is the most common form of dementia, which affects about 46 million people worldwide and is expected to nearly triple by 2050, the companies said. There is currently no medical treatment that can stop or significantly slow the progression of the disease, which is fatal.

“This is an important and meaningful step forward on the path to better understand the Alzheimer’s puzzle,” said Phyllis Ferrell, vice president for Alzheimer’s disease at Lilly.

But those steps can be expensive and uncertain, as Lilly well knows.

In 2010, the Indianapolis drugmaker pulled the plug on another experimental drug, semagacestat, after about a decade of work, after early results from two studies showed the treatment did not slow the disease's progression and was tied to some worsening clinical measures.

Two years later, Lilly said another experimental drug, solanezumab, failed the two primary goals in late-stage clinical trials: to slow both the decline in thinking and daily functioning that occurs in both mild and moderate Alzheimer’s disease. But it did slow mental decline in patients.

Last month, Lilly shares fell nearly 4 percent after Lilly announced it was changing the goal of another late-stage trial of solanezumab. The original goal had two primary outcome measures: changes in participants’ cognition and daily functioning. In the new goal, cognition will remain a primary outcome measure, while function will be a secondary measure.

Some analysts said that news added uncertainty over “what was already a high-risk program.”

Can Lilly finally get a treatment for Alzheimer’s disease into the end zone? It’s been a low, tough grind so far, but the company says it remains committed to finding a breakthrough.