(Reuters) - Merck & Co said on Tuesday it will advance its experimental Alzheimer's drug into late-stage trials among patients with mild to moderate disease, after an independent monitoring board reviewed its safety and recommended the trial continue to recruit patients.
The data monitoring committee gave its blessing to a
Phase III trial involving up to 1,960 patients after examining interim
safety data from a mid-stage trial of 200 patients who had been treated
with the medicine, called MK-8931, for at least three months. The
planned new study, called EPOCH, is expected to conclude in mid-2017,
The medicine works by blocking beta secretase, which
is involved in production of beta-amyloid. Such medicines are known as
Merck will also begin a separate Phase III trial
of the drug, involving 1,500 patients, in so-called "prodromal" patients
who do not yet have dementia.
That study, called APECS, will
enroll patients with mild cognitive problems and potential biomarkers
for Alzheimer's, such as elevated levels of beta amyloid in the brain
and of beta amyloid and the protein tau in spinal fluid. They will be
treated for two years and then assessed for progression toward dementia.
drugs to block beta secretase, although still unproven, are considered
one of the most promising new approaches to slowing progression of
Alzheimer's after an injectable class of medicines meant to block beta
amyloid directly last year failed or fell short in trials conducted by
Pfizer Inc and Eli Lilly and Co.
But safety of BACE inhibitors
became a major concern in June, when Lilly pulled the plug on its own
medication due to liver toxicity.
Although data from Merck's
mid-stage trial of MK-8931 remains blinded, or secret, the data
monitoring committee was allowed to examine the data for hints of safety
issues. Its green light could help ease safety concerns over the
emerging new class of medicines.
"There's good reason to hope that
a BACE inhibitor might help patients, and ours is the first to get the
go-ahead for Phase III" trials, Darryle Schoepp, head of neuroscience at
Merck, said in an interview.
The Merck drug in earlier trials cut
production of a-beta peptide, the building block of beta amyloid
plaque, by 79%, Schoepp said.
J.P.Morgan analyst Chris Schott said
expectations remained "low" for BACE inhibitors following termination
of Lilly's product. But he said Merck's drug could generate annual sales
of more than $5 billion if it succeeds in trials and is approved.