Biotech claims a dubious Alzheimer's 'breakthrough'

What happens when the placebo you use in an Alzheimer's study turns out to work better than your drug? Why, you call it a breakthrough for patients and then decline to answer any detailed questions about it. That appears to sum up the approach at Affiris AG. Cormac Sheridan at BioWorld notes that Affiris's placebo arm, given a substance called AD04, did remarkably well in a Phase II study. In fact, the biotech claimed that 47% of the patients in the AD04 arm demonstrated signs of disease modification. Its drug AD02 didn't fare as well. "You can't achieve that by a placebo effect. This is something that is real and that is defined by the EMA and the FDA as a prerequisite for disease modification," Affiris CEO and co-founder Walter Schmidt told BioWorld Today. Schmidt, though, was less forthcoming about details on AD04, which will have to wait for now. Other Alzheimer's drugs have looked promising in Phase II, perhaps most notably Medivation's Dimebon, which was partnered with Pfizer ($PFE) in a rich deal that foundered when the drug ended up Phase III looking like, well, a placebo. Report