July 22, 2015
By Mark Terry, BioSpace.com Breaking News Staff
Investors hoping to be dazzled by details about Biogen, Inc. and Eli Lilly and Company ’s drug trials for Alzheimer’s disease are feeling let down today, and showing it on the stock market.
It was just Monday when the buzz was building at the Alzheimer’s Association International Conference. Both Eli Lilly and Company (LLY) and Biogen, Inc. were to present data today. Lilly was presenting data on the clinical trial for its drug solanezumab. Although the drug had disappointing clinical trials in 2012, failing to slow the symptoms of Alzheimer’s compared to placebo, Lilly researchers began analyzing a subgroup of AD patients with a mild form of the disease that responded to the drug.
Biogen also presented data today about its drug aducanumab. In a March 20, 2015 announcement, Biogen indicated results of a Phase IIb trial for the drug that showed a significant decrease in amyloid plaque in AD patients. Of particular interest for today’s announcement was new data regarding six milligram dosages.
In previous trials Biogen studied four different doses, a placebo group and a one milligram, three milligram and 10 milligram dosage study. The three and 10 milligram groups showed statistically-significant decrease in amyloid accumulation, with evidence that the decline in brain function slowed. There were some safety concerns over higher dosages.
Both drugs work to clear amyloid plaque from the brain.
Both companies have detailed their most recent results. Biogen announced that the new data was consistent with previously reported results. The 54-week data from the six milligram patients showed a statistically significant decrease of beta amyloid in the brain, but did not show a statistically significant improvement in cognitive decline, although apparently it did show some improvement.
“We are encouraged by these results, which continue to show that treatment of prodromal and mild Alzheimer’s disease patients with aducanumab resulted in a statistically significant, dose-dependent reduction in amyloid plaque, as well as a dose-dependent slowing of cognitive decline,” said Alfred Sandrock, group senior vice president and chief medical officer at Biogen. “We have begun screening patients for our Phase III clinical trials. The results of the PRIME study give us hope that aducanumab may one day make a meaningful difference for people with Alzheimer’s disease.”
Eli Lilly announced the results of solanezumab, indicating that “the treatment effect of solanezumab was preserved within a pre-specified amount in patients with mild Alzheimer’s disease who received solanezumab earlier in the disease compared to patients who began treatment at a later point.”
The point of the Eli study is a little more difficult to understand. What the company did is called a delayed start study. The original 1,322 patients in the first study were allowed to participate in a study extension in which they received the drug, whether they received it or the placebo in the original study. They were then followed for three-and-a-half years. Usually these types of studies are performed to accumulate safety information. What Lilly did was develop a statistical model to determine whether solanezumab is effecting disease progression.
Patients that initially received solanezumab had their symptoms get worse less than patients receiving placebo. Then the placebo group received the drug and the two different groups’ disease progression became similar.
That’s promising and does provide researchers another way of studying Alzheimer’s drugs. Matthew Herper, writing for Forbes, said, “That’s a hugely important contribution on Lilly’s part. But we’re still all left waiting for the data from the upcoming solanezumab studies. The last patient visit in the study should occur in October 2016.”
Investors responded accordingly. dropped 17.87 percent in pre-market trading and is currently trading at $409.50 per share.
Lilly stock dropped 1.68 percent after-hours and currently is trading at $85.57.
So the results of both studies? Promising but not dazzling.
