Sage Therapeutics announced yesterday (20 November) that its Phase II DIMENSION study for dalzanemdor (SAGE-718) failed to meet its primary and secondary endpoints.
Considered to treat cognitive impairment in patients with Huntington’s disease, the drug did not demonstrate a statistically significant difference versus placebo. As a result, Sage has said does not plan to further develop dalzanemdor. It will also close its PURVIEW open-label safety study of the drug.
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Sage’s DIMENSION study lasted 12 weeks and was a double-blind, placebo-controlled Phase II trial. It included 189 patients, randomised to establish the safety and efficacy of dalzanemdor in the treatment of cognitive impairment associated with Huntington’s disease.
The results showed no statistically significant difference in patients using dalzanemdor versus placebo on the primary endpoint of a change from baseline on the Symbol Digit Modalities Test (SDMT) at day 84. Analyses of secondary endpoints also failed to demonstrate statistically significant or clinically meaningful differences between the dalzanemdor and placebo treatment groups.
On safety, the study demonstrated that the drug was generally well-tolerated, and no new safety signals were observed. Sage reported that the majority of treatment-emergent adverse events were mild to moderate in severity.
The dalzanemdor results follow a string of mid-stage failures for Sage, as well as a recent restructuring that saw the company halve its R&D team last month. The restructuring was the second since August 2023 when the company’s depression drug Zurzuvae was licensed only for postpartum treatment, leaving the broader market out of reach.
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By GlobalData“We are disappointed by the results of the DIMENSION study, especially for the individuals and families affected by Huntington’s Disease who have long awaited new treatment options,” said Sage CEO Barry Greene.
“Innovation is desperately needed, and we are immensely grateful to the participants, investigators, and the entire Huntington’s disease community whose unwavering commitment to advancing research helped make this study possible.”
Huntington’s disease is defined by the National Organization for Rare Disorders as “a genetic, progressive, neurodegenerative disorder characterised by the gradual development of involuntary muscle movements affecting the hands, feet, face and trunk and progressive deterioration of cognitive processes and memory (dementia)”.
The global prevalence of Huntington’s disease is thought to be around 2.71 per 100,000 individuals. According to the Huntington Study Group, specific figures are difficult to ascertain, as “demographic differences influence the number and composition of individuals with Huntington’s disease”. Of this point, it reports that Northern European populations are recorded as having the highest prevalence of Huntington’s disease in the world.
According to epidemiologists, figures are set to grow. In its 2021 ‘Huntington’s Disease – Opportunity Assessment and Forecast to 2030‘ report, GlobalData said it expected to see a 4.9% increase in the diagnosis of Huntington’s disease in the three major markets (the US, Germany and the UK) between 2020 and 2030. The report said: “This may be attributable to better diagnosis and changes in the population demographics in these markets.”
