Novel Alzheimer's Drug Appears to Slow Decline

The iADRS is a composite tool that combines scores from the Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog) and the Alzheimer's Disease Cooperative Study-Instrumental Activities of Daily Living (ADCS-iADL). Shares of Biogen Inc, which is developing a similar drug, rose 7%.

Eli Lilly and Company has reported that data from Phase II TRAILBLAZER-ALZ study of its investigational antibody, donanemab, showed a significant slowing of decline in patients with early symptomatic Alzheimer's disease.

However, this theory has been tried and tried again, with a string of failures in the field that includes Lilly's previous Alzheimer's candidate solanezumab.

Donanemab-treated patients showed a 32 percent decline in change from baseline to 76 weeks in the Integrated Alzheimer's Disease Rating Scale (iADRS), according to Lilly.

Also, Lilly's experimental treatment showed consistent improvements in all pre-specified secondary endpoints compared to placebo.

However, donanemab did not reach nominal statistical significance on every secondary endpoint, the company said. In TRAILBLAZER-ALZ, donanemab-treated patients, on average, showed an 84 centiloid reduction of amyloid plaque at 76 weeks compared to a baseline of 108 centiloids (less than 25 centiloids is typical of a negative amyloid scan).

Patients in the study stopped receiving monthly infusions of the drug and were switched to a placebo once their brain plaques reached levels seen in healthy people - a process that took just a few months for some.

He also said the results indicate that "this is as far as you can go with amyloid" and that additional strategies are needed to fully combat the disease.

The full results of the TRAILBLAZER-ALZ study will be presented at a future medical congress and submitted for publication in a peer-reviewed clinical journal. "In addition, we are committed to reproducing and extending these important findings in our second ongoing pivotal donanemab trial, TRAILBLAZER-ALZ 2", said Mark Mintun, M.D., vice president of pain and neurodegeneration, Eli Lilly and Company.

Lilly said it planned to discuss the latest results with regulators to assess the next steps for donanemab, drawing attention to whether its move would affect regulators' decision to grant the nod for Biogen's aducanumab.

The U.S. Food and Drug Administration is reviewing Biogen's application for aducanumab, which, if approved, would be the first new treatment for the memory-robbing disease in decades.

In November 2020, however, the FDA's Peripheral and Central Nervous System Drugs Advisory Committee overwhelmingly voted no on a number of counts regarding the efficacy and evidence supporting the use of this drug in Alzheimer's.

Participating in JP Morgan Healthcare Conference on Monday, Biogen still picked aducanumab as the most promising portfolio.

Law firms claim that Biogen made false or misleading statements during the period.