Novo Nordisk shares drop 10% after Alzheimer’s drug trial misses key target

Novo Nordisk (NVO) announced the top-line results from the 2-year primary analysis of evoke and evoke+ phase 3 trials in early-stage symptomatic Alzheimer’s disease. The two trials were randomized, double-blinded, enrolled a total of 3808 adults and evaluated the efficacy and safety of oral semaglutide compared to placebo on top of standard of care. The decision to pursue an Alzheimer’s disease indication with semaglutide was based on real-world evidence studies, pre-clinical models as well as post-hoc analyses from diabetes and obesity trials. The evoke and evoke+ trials did not confirm superiority of semaglutide versus placebo in the reduction of progression of Alzheimer’s disease, as measured by the change in Clinical Dementia Rating – Sum of Boxes score compared to baseline. While treatment with semaglutide resulted in improvement of Alzheimer’s disease-related biomarkers in both trials, this did not translate into a delay of disease progression. In the evoke trials with patients aged 55-85, suffering from mild cognitive impairment or mild dementia due to Alzheimer’s disease, semaglutide appeared to have a safe and well-tolerated profile consistent with previous semaglutide trials. “Based on the significant unmet need in Alzheimer’s disease as well as a number of indicative data points, we felt we had a responsibility to explore semaglutide’s potential, despite a low likelihood of success. We are proud to have conducted two well-controlled phase 3 trials in Alzheimer’s disease that meet the highest standards of research and rigorous methodology,” said Martin Holst Lange, chief scientific officer and executive vice president of Research and Development at Novo Nordisk. The 1-year extension period in the evoke and evoke+ trials will be discontinued based on the efficacy results observed in the overall study population. Shares of Novo Nordisk are down 10% in pre-market trading.