Sage Therapeutics has ceased the development of dalzanemdor (SAGE-718) after it failed to demonstrate efficacy in a Phase 2 clinical trial for Huntington's disease. The trial, which involved 189 participants, aimed to assess the drug's impact on cognitive impairment associated with the disease. However, results showed no significant difference in cognitive function between those treated with SAGE-718 and those receiving a placebo.
The company's decision to discontinue the program follows unsuccessful trials of dalzanemdor in Alzheimer's and Parkinson's diseases. "We are disappointed by the results ... especially for the individuals and families affected by Huntington’s disease who have long awaited new treatment options," said Sage’s CEO, Barry Greene, in a statement.
Impact on Sage's Pipeline
The discontinuation of SAGE-718 leaves Sage with a depleted research pipeline. Another experimental drug, SAGE-324, also recently failed in a mid-stage tremor study, leading Biogen to return the rights to Sage. These setbacks have prompted significant restructuring within the company, including layoffs of over 165 employees and a reprioritization of early-stage research projects.
Previous Setbacks
In August 2023, the FDA approved Sage's drug Zurzuvae only for postpartum depression, not for major depressive disorder, which significantly limited its commercial potential. Sage and Biogen later abandoned efforts to gain approval for major depression, citing the need for substantial investment and time.
Financial Implications
As of September 30, Sage reported $569 million in cash, cash equivalents, and marketable securities. However, the company's shares have plummeted, losing over 90% of their value in the past year and a half.
Brian Abrahams, an analyst at RBC Capital Markets, suggested that the Huntington’s trial failure was anticipated and that Sage faces a challenging path to profitability, even with significant cost reductions.
