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 The drug is an antibody designed to remove clumps of the
Alzheimer's-related protein beta amyloid from the brain.
Lilly said the mid-stage trial of 272 patients met its main goal of
showing a statistically significant change in clinical decline over
18 months.
Donanemab targets a type of beta amyloid known as N3pG which Lilly
believes can be rapidly cleared, enabling short-term, but durable,
treatment.
Patients in the study stopped receiving donanemab and were switched
to placebo once their brain plaques reached levels seen in healthy
people - a process that took just a few months for some patients.
"This study shows that the presence of amyloid is an important
accelerant of Alzheimer's disease," Daniel Skovronsky, Lilly’s chief
scientific officer, told Reuters.
The results also "tell us that there are other things at play," he
added, saying additional strategies were needed to fully combat
Alzheimer's.
A brain swelling side effect, known as ARIA-E, occurred in 27% of
patients treated with donanemab, the company said.
"Alzheimer's disease is uniformly fatal ... I think this safety
profile matched with this efficacy profile is something that we can
be excited about," Skovronsky said.
Lilly said donanemab also showed positive results in the trial's
secondary endpoints measuring cognition and function, but did not
reach statistical significance on all of them.
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 The company is continuing to
study the drug in a second, 500-patient trial.
Lilly, along with companies like Biogen Inc and
Eisai Co Ltd, is one of the last large
drugmakers pursuing treatments for Alzheimer's -
a disease that afflicts nearly 6 million
Americans and millions more worldwide.
The U.S. Food and Drug Administration is
reviewing Biogen's application for aducanumab,
which also targets amyloid plaques.
Biogen said one of its two pivotal aducanumab
studies showed a statistically significant
benefit in slowing cognitive and functional
decline, but a second trial missed that goal,
showing benefit only for some patients who got a
high dose for at least 10 months.
Lilly said full trial results would be presented
at a future medical meeting and submitted for
publication in a peer-reviewed clinical journal.
(Reporting by Deena Beasley; Editing by Clarence
Fernandez)
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