April 21, 2015
By Mark Terry, BioSpace.com Breaking News Staff
Alzheimer’s drug research is a wasteland littered with failed attempts. Swiss-based Roche indicated today that after recent positive data from a Massachusetts-based Biogen clinical trial it has “renewed confidence” in its own efforts in the market.
Biogen announced the results of a Phase Ib trial on March 20, 2015 for its compound, aducanumab, showing a significant reduction in amyloid plaque in patients with Alzheimer’s disease. Amyloid plaque is one of the substances found in the brains of Alzheimer’s patients that are linked to the disease.
“This is the first time an investigational drug for Alzheimer’s disease has demonstrated a statistically significant reduction on amyloid plaque,” said Alfred Sandrock, group senior vice president and chief medical officer of Biogen in a statement, “as well as a statistically slowing of clinical impairment in patients with prodromal or mild disease.”
Roche’s experimental compound, gantenerumb, has similar activity to Biogen’s aducanumab. However, Roche had disappointing results from a late-stage Phase III study of gantenerumab, as well as similarly poor results for a Phase II trial of crenezumab.
However, Roche is in the processing or reevaluating those two programs. “We’re not at a stage where we’ve made a final decision on those two programs,” said Roche’s Pharmaceuticals Division chief operating officer Daniel O’Day in a statement, “but we’re encouraged because the data that was presented from Biogen showed a concordance between dose level, between plaque removal and between clinical effect.”
On Dec. 19, 2014, Roche announced it was discontinuing SCarlet RoAD, a phase III study of gantenerumab on pre-dementia Alzheimer’s disease. The safety of the drug was confirmed, but was canceled “based on results of a pre-planned futility analysis and recommendation by the independent Data Monitoring Committee.”
On July 16, 2014, the company announced that the Phase II trial for crenezumab did not meet its co-primary endpoints. The findings were not completely disappointing, showing a positive trend in cognition for people with mild disease who received a high dose of the drug intravenously.
Tim Anderson, an analyst with Bernstein, suggested that O’Day’s recent statements might indicate Roche plans to push crenezumab to a Phase III trial.
In March, Jeremy Hunt, the United Kingdom’s health secretary, announced the creation of the Dementia Discovery Fund at the World Health Organization’s First Ministerial Conference on Global Action Against Dementia. To date the fund has raised more than $100 million. That fund has brought in GlaxoSmithKline (GSK), Johnson & Johnson (JNJ), Eli Lilly and Company (LLY), Pfizer Inc. (PFE) and Biogen (BIIB).
The British government donated $22 million. GSK threw another $25 million into the fund and J&J offered $10 million. The remaining companies rounded out the initial $100 million. The fund will behave like a venture capital fund to help identify promising directions for Alzheimer’s research and dementia.
