Dec 10 (Reuters) - Merck & Co said it will begin two late-stage trials of its experimental Alzheimer's drug, one of the industry's best hopes for slowing the memory-robbing disease, after an independent monitoring board reviewed its safety and recommended that more patients be recruited for studies.
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, Merck said on Tuesday.
The medicine works by blocking an enzyme called beta secretase that is involved in production of beta-amyloid, a protein that creates brain plaques considered a major cause of the progressive disease. Such medicines are known as BACE inhibitors.
"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.
Merck will also begin a separate Phase III trial of the drug, involving 1,500 patients, in "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.
The trial is predicated on the theory that early intervention may be crucial, and that once dementia develops it may be too late to seriously arrest Alzheimer's disease.
"The prodromal trial is exciting because it may teach us whether we can prevent or slow down the onset of dementia," Schoepp said.
An estimated 5 million Americans have Alzheimer's, the most common cause of dementia. More than 38 million people worldwide are believed to have dementia, including Alzheimer's disease, and those numbers are expected to rise as more people live longer.
Unlike heart disease and cancer, no major advancements have been seen in Alzheimer's drug research since the first treatment was approved in 1993 by U.S. regulators.
Current Alzheimer's drugs, including Namenda from Forest Laboratories Inc and generic forms of Pfizer Inc's Aricept (donepezil), can minimally and briefly help memory and ability to perform daily functions, but do not slow the disease.
Oral drugs to block beta secretase have taken center stage after an injectable class of medicines, meant to remove beta amyloid plaque after it has already formed, failed or fell short last year in trials conducted by Pfizer Inc and Eli Lilly and Co.
Safety of the new drugs became a major concern in June, when Lilly pulled the plug on its own BACE inhibitor due to liver toxicity. Merck, Johnson & Johnson, Roche Holding AG and Eisai Co Ltd are still in the race.
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.
The Merck drug in earlier trials cut production of a-beta peptide, the building block of beta amyloid plaque, by 79 percent, Schoepp said.
"You're turning off the faucet, shutting at its source the pathway that forms a-beta peptide," said Schoepp. The toxic peptides clump together to form beta amyloid plaques in the brain that are a hallmark of the disease.
J.P.Morgan analyst Chris Schott said expectations remained "low" for BACE inhibitors following the 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.
Merck shares slipped 0.4 percent to $49.35 in afternoon trading on the New York Stock Exchange, amid moderate declines for the drug sector.
Our 2024 Coverage Needs You
It's Another Trump-Biden Showdown — And We Need Your Help
The Future Of Democracy Is At Stake
Our 2024 Coverage Needs You
Your Loyalty Means The World To Us
As Americans head to the polls in 2024, the very future of our country is at stake. At HuffPost, we believe that a free press is critical to creating well-informed voters. That's why our journalism is free for everyone, even though other newsrooms retreat behind expensive paywalls.
Our journalists will continue to cover the twists and turns during this historic presidential election. With your help, we'll bring you hard-hitting investigations, well-researched analysis and timely takes you can't find elsewhere. Reporting in this current political climate is a responsibility we do not take lightly, and we thank you for your support.
Contribute as little as $2 to keep our news free for all.
Can't afford to donate? Support HuffPost by creating a free account and log in while you read.
The 2024 election is heating up, and women's rights, health care, voting rights, and the very future of democracy are all at stake. Donald Trump will face Joe Biden in the most consequential vote of our time. And HuffPost will be there, covering every twist and turn. America's future hangs in the balance. Would you consider contributing to support our journalism and keep it free for all during this critical season?
HuffPost believes news should be accessible to everyone, regardless of their ability to pay for it. We rely on readers like you to help fund our work. Any contribution you can make — even as little as $2 — goes directly toward supporting the impactful journalism that we will continue to produce this year. Thank you for being part of our story.
Can't afford to donate? Support HuffPost by creating a free account and log in while you read.
It's official: Donald Trump will face Joe Biden this fall in the presidential election. As we face the most consequential presidential election of our time, HuffPost is committed to bringing you up-to-date, accurate news about the 2024 race. While other outlets have retreated behind paywalls, you can trust our news will stay free.
But we can't do it without your help. Reader funding is one of the key ways we support our newsroom. Would you consider making a donation to help fund our news during this critical time? Your contributions are vital to supporting a free press.
Contribute as little as $2 to keep our journalism free and accessible to all.
Can't afford to donate? Support HuffPost by creating a free account and log in while you read.
As Americans head to the polls in 2024, the very future of our country is at stake. At HuffPost, we believe that a free press is critical to creating well-informed voters. That's why our journalism is free for everyone, even though other newsrooms retreat behind expensive paywalls.
Our journalists will continue to cover the twists and turns during this historic presidential election. With your help, we'll bring you hard-hitting investigations, well-researched analysis and timely takes you can't find elsewhere. Reporting in this current political climate is a responsibility we do not take lightly, and we thank you for your support.
Contribute as little as $2 to keep our news free for all.
Can't afford to donate? Support HuffPost by creating a free account and log in while you read.
Dear HuffPost Reader
Thank you for your past contribution to HuffPost. We are sincerely grateful for readers like you who help us ensure that we can keep our journalism free for everyone.
The stakes are high this year, and our 2024 coverage could use continued support. Would you consider becoming a regular HuffPost contributor?
Dear HuffPost Reader
Thank you for your past contribution to HuffPost. We are sincerely grateful for readers like you who help us ensure that we can keep our journalism free for everyone.
The stakes are high this year, and our 2024 coverage could use continued support. If circumstances have changed since you last contributed, we hope you'll consider contributing to HuffPost once more.
Support HuffPostAlready contributed? Log in to hide these messages.