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(Sharecast News) - Novo Nordisk's attempt to repurpose its blockbuster diabetes and weight-loss drug semaglutide for Alzheimer's disease suffered a decisive setback on Monday, after two major phase three trials failed to show that the medicine could slow cognitive decline in early-stage patients.
Shares in the Danish drugmaker fell in early trading in Copenhagen following the announcement, marking a further blow in a difficult year for the company.
The 'evoke' and 'evoke+' studies, which together enrolled 3,808 adults aged 55 to 85 with mild cognitive impairment or mild dementia due to Alzheimer's, found that daily oral semaglutide showed no statistically significant benefit over placebo in reducing disease progression.
Novo Nordisk said the trials measured changes in patients' 'clinical dementia rating - sum of boxes' scores over 104 weeks but "did not confirm superiority of semaglutide versus placebo in the reduction of progression of Alzheimer's disease."
Although the drug improved several Alzheimer's-related biomarkers, the gains did not translate into a measurable slowing of cognitive or functional decline.
"While semaglutide did not demonstrate efficacy in slowing the progression of Alzheimer's disease, the extensive body of evidence supporting semaglutide continues to provide benefits for individuals with type 2 diabetes, obesity, and related comorbidities," said Martin Holst Lange, Novo's chief scientific officer and executive vice president for research and development.
He added that the company had "a responsibility to explore semaglutide's potential, despite a low likelihood of success," given the scale of unmet need in Alzheimer's.
Novo Nordisk said it would discontinue the planned one-year extension phase of both trials and would present full results at upcoming scientific meetings, including the Clinical Trials in Alzheimer's Disease conference on 3 December.
The failure was also a strategic setback for Novo as it looked for growth opportunities beyond its core diabetes and obesity franchises.
Analysts had cautioned that its Alzheimer's programme carried long odds, with UBS estimating only a 10% chance of success and a senior Novo executive previously describing the trials as a "lottery ticket".
At 1301 CET (1201 GMT), shares in Novo Nordisk were down 8.32% in Copenhagen at DKK 279.30.
Reporting by Josh White for Sharecast.com.