Merck stopping late stage
study as another Alzheimer's drug fails
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[February 15, 2017]
(Reuters) - Merck & Co Inc said on
Tuesday it will halt a late-stage trial of an Alzheimer's drug after it
was determined that it had no chance of working, marking the latest in a
long line of crushing disappointments in efforts to find an effective
treatment for the mind-wasting disease.
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The company was testing its drug, verubecestat, in patients with
mild to moderate Alzheimer's disease. But an independent data
monitoring committee determined that there was "virtually no chance
of finding a positive clinical effect" and recommended the trial be
stopped for futility.
The news sent Merck shares down nearly 2 percent in after hours
trading.
Verubecestat belongs to a class of experimental Alzheimer's drugs
called BACE1 inhibitors that target an enzyme involved in the
formation of the toxic amyloid protein that turns into plaques in
the brains of Alzheimer’s patients.
Several companies are pinning hopes on Alzheimer's treatments using
the BASE inhibitor mechanism, including Eli Lilly and Co, Biogen and
Novartis in collaboration with Amgen Inc.
Lilly previously endured multiple failures with its solanezumab,
which also targets beta amyloid, but in a different way. In the most
recent setback, Lilly said that drug failed to slow declines in
mental capacity of patients with even mild symptoms.
Researchers are increasingly focusing on attacking the disease
earlier as it appears likely that once symptoms have taken hold
current approaches fail to work.
Merck said another study of its drug in patients with prodromal, or
very early, Alzheimer's disease would continue with results expected
by February 2019.
Patients with prodromal Alzheimer's disease have objective memory
problems but relatively normal functioning in activities of daily
living.
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Blinded clinical trials use independent monitors to watch for any
unexpected safety problems that may crop up. They can also recommend
stopping a study early if it becomes clear that a drug is going to
fail or if the data looks so compelling that it believes the
treatment should be offered to those getting a placebo or other
standard treatments.
Merck shares fell to $64.48 in extended trading from a close at
$65.66.
(Reporting by Bill Berkrot in New York and Akankshita Mukhopadhyay
in Bengaluru; Editing by Maju Samuel and Diane Craft)
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