Is Biogen’s Aducanumab for Alzheimer’s the Holy Grail or Cold Fusion?

Whenever a drug fails an Alzheimer’s clinical trial, analysts, investors, and industry watchers immediately turn to look at Biogen. Will the company’s aducanumab be the one? Will it be the drug that will actually break the string of more than 150 drug failures? Today, Roche announced that it was discontinuing two of its Alzheimer’s Phase III trials, CREAD I and 2, after a pre-planned interim analysis. The studies investigated crenezumab in patients with early, prodromal to mild, sporadic Alzheimer’s disease. Roche was working with AC Immune on developing the drug.
Crenezumab appeared safe, but the interim analysis showed the drug was unlikely to meet the primary endpoint of change from baseline in Clinical Dementia Rating-Sum of Boxes (CDR-SB) Score. The companies expect to present the data at an upcoming medical conference. Roche indicated that a crenezumab trial in Colombia as part of the Alzheimer’s Prevention Initiative (API) will continue. It also says it is committed to continuing work on Alzheimer’s, including Phase III trials with gantenerumab and a Phase II anti-tau trial. The Colombia trial focuses on cognitively healthy patients who have an autosomal dominant mutation that places them at risk to develop familial Alzheimer’s disease. It is a five-year trial in collaboration with the Banner Institute funded by the National Institute on Aging.