Sage Therapeutics announced it will abandon the development of dalzanemdor (SAGE-718) after the drug failed to best placebo in a phase 2 study of cognitive impairment associated with Huntington’s Disease.
According to Sage, in the phase 2 DIMENSION study, dalzanemdor did not demonstrate a statistically significant difference versus placebo on the primary endpoint, the change from baseline on the Symbol Digit Modalities Test — a measure of sustained attention, processing speed, visual scanning and motor speed — at day 84. Analyses of secondary endpoints did not demonstrate statistically significant or clinically meaningful differences either.
Given the DIMENSION findings, Sage also plans to close the ongoing PURVIEW Study, an open-label safety study of dalzanemdor in participants with HD.
It has been rough goings for the Massachusetts-based biotech. Back in mid-October, the company revealed a re-org intended to support the ongoing launch of Zurzuvae in postpartum depression and focus pipeline development efforts on dalzanemdor. The reorg came with leadership changes, as well as a 33% workforce reduction, which included 55% of the company’s R&D team.
In August 2023, Zurzuvae — co-developed by Sage and Biogen — became the first FDA approved oral drug designed to treat postpartum depression in adults. At the same time, the FDA responded to the larger indication — major depressive disorder — with a Complete Response Letter.