Eli Lilly: Alzheimer’s drug may slow disease’s progress

INDIANAPOLIS — Eli Lilly and Co. hoped to salvage its Alzheimer’s drug solanezumab with new studies.

Those hopes are still alive.

Results from the first of the studies Lilly is using to try to breathe new life into solanezumab suggest that the drug seems to delay the progress of Alzheimer’s disease in its early stages by 34%.

Lilly is releasing the much-anticipated study results Wednesday at the Alzheimer’s Association International Conference in Washington, D.C.

The study results come with caveats. The drug didn’t reverse or stop the ravages of Alzheimer’s. And its disease-slowing impact applied only to patients with mild symptoms of Alzheimer’s, an incurable disease that destroys brain function.

Nonetheless, the study results are “certainly very promising,” said Dr. Eric Siemers, a neurologist and distinguished medical fellow at Lilly. “If you could slow a (progressive disease) down by 34%, I think that’s a good thing.”

Solanezumab, once one of Lilly’s most promising drugs in development, was on the ropes three years ago when initial late-phase studies failed to show efficacy in Alzheimer’s patients in all stages of the disease. But instead of scrapping the drug, Lilly decided to narrow its development efforts to focus only on patients with mild Alzheimer’s, hoping the drug would prove effective for them.

Siemers acknowledged some people might not consider a 34% delay in Alzheimer’s symptoms to be medically worthwhile, since treatment only slows the disease’s ravages.

“Is it clinically meaningful? That’s up for discussion,” he said.

The Lilly study of 1,322 patients was the first to use a delayed-start approach to measure the efficacy of a neuroscience drug. Lilly compared Alzheimer’s patients who took its experimental drug with those who got the drug later in the trial to assess the drug’s impact on the disease’s progression. Only patients with mild dementia were measured. The study ran as long as 108 weeks.

Dr. Martin Farlow, a professor of neurology at Indiana University School of Medicine who is involved in testing the Lilly drug on patient volunteers, said he was excited to see the latest study results.

“I think it’s significant,” he said of the 34% slowdown in the disease’s progression. “I would be happier if it was 100%. But it’s a step. That additional time of having fewer symptoms ... it is clinically significant.”

Lilly has other studies underway on solanezumab. Regulatory approval will depend on how well the drug fares in those studies.

The drug is thought to work by interfering with the formation of extracellular deposits of protein, called beta-amyloid, that form into plaque in the brains of Alzheimer’s patients.

Whether beta-amyloid causes Alzheimer’s is disputed.

“The amyloid hypothesis has been on a bit of a roller coaster” in scientific debates, Siemers said. “But I think it’s on a bit of an upswing right now.”