New details emerge on drug that may slow Alzheimer’s disease

Dementia causes stigma

Dementia causes stigma

A fresh look at the ENGAGE and EMERGE trials at the Clinical Trials on Alzheimer's Disease (CTAD) didn't include any new results, but covered the same ground as Biogen' October update, which resurrected the amyloid-targeting drug - partnered with Eisai - after it was written off earlier in the year. If the drug succeeds in the late-stage study, she said the value of stock, whose price-to-earnings ratio for the next 12 months has been trailing in the negative, could more than double.

A much-anticipated presentation of data from Biogen's pivotal trials programme for Alzheimer's disease candidate aducanumab has done little to boost confidence in the drug's prospects.

However, some experts say that changes during the study and unusual analyses make the results hard to interpret and the risks and benefits of the drug unclear, the AP reported. He is on an FDA panel likely to review the drug but won't participate because he was involved in one of the studies.

Laurie Ryan, a dementia scientist at the National Institute on Aging, agreed.

Some doctors who consult for the drug's developers disagreed.

Aducanumab aims to help the body clear harmful plaques, or protein clumps, from the brain.

EMERGE gave a positive if modest readout for the high-dose aducanumab arm on cognition scores, but ENGAGE didn't show clinical efficacy for the drug and the general sense seems to be that the dataset doesn't meet the FDA's usual criteria for approval.

More than 5 million people in the United States and millions more worldwide have Alzheimer's.

Prior to the publication of the interim analysis data, SVB Leerink analyst Marc Goodman had said the drug faces less regulatory risk and would require less resources as it seeks to treat symptoms of the disease rather than the underlying cause.

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