Disappointment for Sage Therapeutics as Parkinson’s Disease Trial Misses Endpoint

In a crushing disappointment for Sage Therapeutics (Nasdaq: SAGE) and the Parkinson’s disease community, the company reported on Wednesday that its double-blind, placebo-controlled Phase 2 study of dalzanemdor (SAGE-718) in Parkinson’s Disease (PD) did not meet its primary endpoint. Sage’s shares rallied +4.30% in intraday trading on Thursday after a difficult day on Wednesday. Based on the data, the company says it does not plan any further development of dalzanemdor in PD.

The company expects to report on its other clinical studies throughout the year, including topline data from its SURVEYOR Study in people with Huntington’s Disease (HD) cognitive impairment in mid-2024 and in late-2024, topline data from its LIGHTWAVE Study in people with mild cognitive impairment and mild dementia in Alzheimer’s Disease, and topline data from its DIMENSION Study in people with HD cognitive impairment.

Barry Greene, Chief Executive Officer at Sage Therapeutics, said the company is disappointed by the results of the Phase 2 PRECEDENT study given the significant burden of mild cognitive impairment on people and families affected by Parkinson’s Disease.

“Although cognitive impairment is common in neurodegenerative disorders, the underlying pathophysiology and symptomatology in Parkinson’s disease is distinctive, and these results do not necessarily predict results with dalzanemdor in other neurodegenerative conditions. We look forward to the topline data readouts from the Phase 2 studies in Huntington’s disease and Alzheimer’s disease expected later this year,” said Mr. Greene.

The company’s study was designed to evaluate the safety and efficacy of dalzanemdor (SAGE-718) dosed over six weeks. A total of 86 participants were enrolled and randomized. The study did not meet its primary endpoint of demonstrating statistically significant difference from baseline in participants treated with once-daily dalzanemdor versus placebo. Dalzanemdor was found to be well-tolerated, and there were no new safety signals observed.

About Sage Therapeutics

Sage Therapeutics (Nasdaq: SAGE) is a biopharmaceutical company committed to our mission of pioneering solutions to deliver life-changing brain health medicines, so every person can thrive. Sage developed the only two FDA-approved treatments indicated for postpartum depression and is advancing a robust pipeline to target unmet needs in brain health. Sage was founded in 2010 and is headquartered in Cambridge, Mass. Find out more at www.sagerx.com or engage with us on Facebook, LinkedIn, Instagram, and X.