Roche Alzheimer's Drug Fails, but Should Trials Proceed Anyway?
By Clinical Informatics News Staff
July 16, 2014 | Matthew Herper has a breakdown of the Roche’s failed Alzheimer’s trial data at Forbes today. While the trial itself didn’t succeed, Herper argues that it could still provide some hope for Alzheimer’s treatment, and suggest better trial design.
The drug, crenezumab, attempts to slow Alzheimer’s progression by blocking the accumulation of a protein called amyloid beta. It works similarly to previous beta amyloid blockers, but without the dangerous brain swelling associated with a previous drug developed by Pfizer, Johnson & Johnson, and Elan. Without those side effects, Roche’s drug could be given in higher doses, and it was the higher dose groups that showed the most response.
Herper acknowledges that the drug is still a long shot, but for the potentially enormous market associated with Alzheimer’s, drug companies are willing to make bets here they won’t make elsewhere.
The interesting note in terms of trial design, is how—and when—Roche is testing their theories. “Roche is taking an innovation it learned in cancer—to use the mid-stages of the clinical trial process to conduct rigorous tests of an experimental medicine’s potential —here,” Herper says.
Generally the drug wouldn’t be advanced into Phase 3 based on the results, but Herper says that may not be the best move here. Alzheimer’s progression can be hard to test—Roche used two cognitive tests—and it looks like the drug may be most active in the earliest stages of disease, which is even harder to differentiate from other forms of dementia.
Further testing certainly seems warranted. “The data are just good enough that it’s hard not to say Roche should keep going,” Herper concludes.
Read the Forbes story.
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