By Ransdell Pierson and Debra Sherman
Mon Dec 3, 2012 3:35pm EST
(Reuters) – Merck Co Inc has changed to a forefront of Alzheimer’s illness investigate by starting a mid-stage investigate of a drug from a new category of verbal medicines that aim to close down prolongation of a protein compared with a memory-robbing disease.
The drugmaker pronounced on Monday it had started a hearing to weigh a reserve and efficiency of a supposed BACE inhibitor, named MK-8931, in patients with mild-to-moderate Alzheimer’s disease.
The Phase II trial, that will review a drug with a placebo, is a global, multi-center investigate that includes a organisation of 200 patients to exam safety. The investigate is approaching eventually to enroll adult to 1,700 patients in a categorical Phase III trial.
Darryle Schoepp, control of neuroscience during Merck, pronounced drugmakers have been perplexing for a decade to rise treatments that detain Alzheimer’s illness by restraint beta secretase, an enzyme concerned in prolongation of poisonous beta amyloid proteins that form board in a mind believed to be a writer to Alzheimer’s disease.
By restraint beta secretase in progressing Phase we trials, a Merck drug slashed by some-more than 90 percent a levels of beta amyloid protein present in cerebrospinal fluid.
“It’s like shutting a faucet so zero comes out,” Schoepp pronounced in an interview. Merck hopes that by preventing prolongation of beta amyloid – a categorical member of mind board – a drug will forestall a worsening of symptoms among patients with mild-to-moderate stages of a disease.
Should a Merck drug infer protected in a Phase II reserve trials, Schoepp pronounced a medicine could eventually be tested in “prodromal” patients, or those with a really commencement signs of Alzheimer’s. They would embody people with really amiable memory problems who have also been shown by blood tests or mind scans to have worrisome initial buildup of amyloid board or who have other “bio markers” compared with a on-going memory-robbing disease.
A successful Alzheimer’s diagnosis could reap billions of dollars in annual sales. But many experts trust diagnosis contingency be delivered before patients uncover signs of insanity since once that happens, mind repairs might be irreversible.
U.S. drugmaker Eli Lilly is also contrast a beta secretase inhibitor, as good as another initial drug called solanezumab that has shown hints of efficiency in Phase III studies. Solanezumab also targets beta amyloid protein, though by a opposite resource than beta secretase blockers.
“In further to solanezumab, that is now in Phase III clinical development, in Jul 2012 Lilly modernized a homegrown beta secretase inhibitor into Phase II clinical growth for a intensity to delayed a course of this harmful disease,” a Lilly orator said.
Schoepp remarkable that a Merck drug is a pill, since solanezumab is given by intravenous infusion. He combined that solanezumab is believed to work by stealing some board already deposited in a brain, since beta secretase inhibitors directly meddle with prolongation of a beta amyloid proteins that form a plaque.
“Our drug attacks a amyloid pathway directly. We’re preventing it during a beginning. You can’t get board if we don’t make these” protein fragments, he said.
EQUAL FOOTING
Lilly is deliberate forward of a a rivals in Alzheimer’s investigate after solanezumab, in Phase III trials, was shown in Aug to delayed cognitive declines in patients with amiable symptoms of a disease. However, a drug unsuccessful a altogether idea of loitering cognitive and earthy decrease in patients with mild-to-moderate Alzheimer’s.
The start of Merck’s new hearing of MK-8931 could put a association on an equal balance with Lilly in a competition for a initial authorized drug to check swell of a disease.
Merck’s drug appears roughly to wholly forestall a arrangement of new beta amyloid, a poisonous proteins that lead to plaques in a brain, while a Lilly drug acts by stealing existent plaques, according to Mark Schoenebaum, an researcher with ISI Group.
“We do not trust that Merck has any clinical efficiency information during this indicate on that it is basing a Phase II/III ‘go’ decision. Thus, one contingency still perspective a Phase III as rarely speculative,” Schoenebaum wrote in a investigate note.
Assuming a U.S. Food and Drug Administration asks Lilly to control another assenting Phase III hearing on a drug, a Merck drug is on roughly a same timeline to intensity capitulation as a Lilly drug, he said.
If a FDA approves a Lilly drug on a existent data, something Schoenebaum thinks is unlikely, afterwards Lilly would be about 3 years ahead, he added.
Merck shares were adult 20 cents, or 0.45 percent during $44.50 in afternoon trade on a New York Stock Exchange, while Lilly shares were down 10 cents during $48.94.
Earlier this year, Roche Holding AG some-more than doubled a distance of a clinical hearing of a initial Alzheimer’s drug, gantenerumab, in patients who have early Alzheimer’s though have not nonetheless grown dementia, putting it in a vanguard of attempts to locate a illness in early stages.
(Reporting by Debra Sherman in Chicago and Ransdell Pierson in New York; modifying by Gerald E. McCormick, John Wallace, Matthew Lewis and Dan Grebler)
Source: Health Medicine Network