Merck & Co Inc has started a new trial of its experimental Alzheimer’s drug, the first mid-stage clinical trial of a promising new class of oral medicines that has the potential to shut down the production of a protein that many researchers believe is the primary cause of the disease.
The drugmaker said on Monday it had started the trial to evaluate the safety and effectiveness of the drug, MK-8931, in patients with mild-to-moderate Alzheimer’s disease.
The Phase II trial, which will compare the drug with a placebo, is a global, multi-center study that includes a group of 200 patients to test safety. The study is expected to eventually enroll up to 1,700 patients in the main Phase III trial.
The drug is the first of its kind to advance to this stage of clinical research.
Eli Lilly and Co is considered the front runner in Alzheimer’s research after its drug solanezumab, in a Phase III trial, was shown in August to slow down cognitive declines in patients with mild symptoms of Alzheimer’s disease. However, the drug failed its overall goal of delaying cognitive and physical decline in patients with mild to moderate Alzheimer’s.
The start of Merck’s new trial of MK-8931 could put the company on an equal footing with Lilly in the race for the first approved drug to delay the progress of the disease.
The Lilly drug is administered intravenously, while the Merck drug is taken orally.
Merck’s drug appears to almost entirely prevent the formation of new beta-amyloid, the toxic proteins that lead to plaques in the brain, while the Lilly drug acts by removing existing plaques, according to Mark Schoenebaum, an analyst with ISI Group. Amyloid plaques are linked to Alzheimer’s disease.
“We do not believe that Merck has any clinical efficacy data at this point upon which it is basing its Phase II/III ‘go’ decision. Thus, one must still view the Phase III as highly speculative,” Schoenebaum wrote in a research note.
Assuming the U.S. Food and Drug Administration asks Lilly to do another confirmatory Phase III trial on its drug, the Merck drug is on roughly the same timeline to potential approval as the Lilly drug, he said.
If the FDA approves the Lilly drug on its existing data, something Schoenebaum thinks is unlikely, then Lilly would be about three years ahead, he added.
Merck shares were up 30 cents to $44.60 in morning trade on the New York Stock Exchange, while Lilly shares were down 10 cents to $48.94.
Earlier this year, Roche Holding AG more than doubled the size of a clinical trial of its experimental Alzheimer’s drug gantenerumab in patients who have early Alzheimer’s but have not yet developed dementia, putting it in the vanguard of attempts to catch the disease in its early stages.
A successful Alzheimer’s treatment could reap billions of dollars in annual sales. But many experts believe treatment must be delivered before patients show signs of dementia because brain damage may be irreversible after that point.
(Reporting by Debra Sherman in Chicago and Ransdell Pierson in New York; Editing by Gerald E. McCormick and John Wallace)
By Ransdell Pierson and Debra Sherman