December 9, 2016
By Mark Terry, BioSpace.com Breaking News Staff
Biogen released early data from its Phase Ib clinical trial of its Alzheimer’s drug, aducanumab, and it has investors both relieved and pleased.
The bottom line of the data indicates that of the more than 100 patients receiving the drug showed a drop in Alzheimer’s-related beta-amyloid plaque in the brain, as well as continued to show a slowing of cognitive declines. Early studies have shown a potentially serious side effect that resulted in swelling in the brain. The new data indicates that increasing the dosages incrementally significantly reduces the likelihood of that happening.
The data appears consistent with research presented in March.
The data is being presented today at the 9th Clinical Trials on Alzheimer’s Disease (CTAD) conference in San Diego.
“The data at CTAD support the positive results we have seen in our Phase Ib study of aducanumab, and they provide insight into the observed effects in patients treated for up to two years,” said Samantha Budd Haeberlein, vice president, clinical development at Biogen, in a statement. “We are committed to advancing our global Phase III program for aducanumab as well as the scientific understanding of Alzheimer’s disease so we can help identify a treatment for the many people affected by this terrible disease.”
The data concluded, “Titration dosing of aducanumab up to 10 mg/kg resulted in significant reductions in amyloid plaque burden during 12 months of treatment in ApoE e4-positive patients with prodromal or mild AD compared with placebo. The clinical effects in the titration cohort were generally consistent with those observed in the fixed dosing cohorts1 and the slowing of decline on the CDR-SB was statistically significant with titrated aducanumab versus placebo.”
Biogen popped at the news yesterday, after data to be published today was leaked. It is currently trading at $305.60.
Although the Phase Ib data is very promising, many Alzheimer’s drugs have failed in Phase III trials. Most recently, Eli Lilly ’s solanezumab failed to meet its primary endpoint in its EXPEDITION3 Phase III clinical trial. Patients didn’t show significant improvement versus placebo in mid-stage trials, then changed the study design to have a single primary endpoint, improvement in cognition. But there was no statistical slowing in cognitive decline in the new study.
Solanezumab and aducanumab are similar drugs, both targeting beta-amyloid. The Lilly failure made a number of analysts question the validity of the beta-amyloid hypothesis, although Biogen’s new data would seem to support the hypothesis. Aducanumab is believed to be more potent than solanezumab. It’s also possible that the primary difference is patient population. Reuters wrote, “Some Alzheimer’s experts have suggested the approach might work very early in the course of the disease. They said once brain plaques can be observed it may already be too late for the drugs to provide significant benefit.”
Meanwhile, Biogen continues enrollment in its Phase III trials of the drug, which will include up to 3,000 people in more than 20 countries.
