Sage Halts Parkinson's Drug Development Following Phase II Failure

Sage Therapeutics encountered a setback with its oral drug candidate, dalzanemdor, which did not meet its targets in a Phase II trial for Parkinson's disease. This led to the company discontinuing its Parkinson's program and its stock price fell by 19% in premarket trading. The PRECEDENT study involved 86 Parkinson's patients with mild cognitive impairment, who were given either the drug or a placebo. Dalzanemdor, intended for cognitive issues linked to NMDA receptor dysfunction, failed to show significant improvements in cognitive test scores compared to the placebo after 42 days.

Despite its safety in the trial, the drug did not outperform the placebo in any exploratory endpoints, prompting Sage to halt further development for Parkinson's. However, dalzanemdor will still be pursued in Phase II trials for Huntington's disease and for mild cognitive impairment and mild dementia in Alzheimer's disease, with results expected in mid-2024 and late 2024.

Sage's CEO, Barry Greene, expressed disappointment but noted that the study's outcome does not foretell the drug's performance in other neurodegenerative conditions. He emphasized the differences in the diseases' underlying mechanisms, despite targeting similar cognitive impairments.

This latest development follows a series of challenges for Sage, including a 40% staff reduction in August 2023 after the FDA rejected zuranolone for major depressive disorder. The medication was approved only for postpartum depression, a smaller market than anticipated, and is now marketed as Zurzuvae. This approval follows Sage's first postpartum depression drug, which was administered intravenously.

The company's recent announcement adds to a history of ups and downs in the pharmaceutical industry, where drug development is a complex and often unpredictable process. The focus now shifts to the upcoming results of dalzanemdor's trials in other conditions, which will determine its future in the field of neurodegenerative diseases.