Exhibit 99.1
Sage Therapeutics Announces Topline Results from the Phase 2 DIMENSION Study of Dalzanemdor
(SAGE-718) in the Treatment of Cognitive Impairment Associated with Huntingtons Disease
- The Phase 2 DIMENSION Study did not meet its primary endpoint
- Dalzanemdor was generally well-tolerated; no new safety signals were observed
- Based on these data, the Company does not plan further development of dalzanemdor
CAMBRIDGE, Mass. November 20, 2024 Sage Therapeutics, Inc. (Nasdaq: SAGE) today announced topline results from
the Phase 2 DIMENSION Study of dalzanemdor (SAGE-718) in participants with cognitive impairment (CI) associated with Huntingtons Disease (HD). In the 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 (SDMT) at Day 84. Analyses of secondary endpoints did not demonstrate statistically significant or clinically
meaningful differences in participants treated with dalzanemdor compared to placebo. Based on these results, the Company does not plan further development of dalzanemdor.
We are disappointed by the results of the DIMENSION Study, especially for the individuals and families affected by Huntingtons Disease who have
long awaited new treatment options, said Barry Greene, Chief Executive Officer, Sage Therapeutics. Innovation is desperately needed, and we are immensely grateful to the participants, investigators, and the entire Huntingtons
Disease community whose unwavering commitment to advancing research helped make this study possible.
DIMENSION Study Results
The DIMENSION Study was a 12-week, double-blind, placebo-controlled Phase 2 study to evaluate the effects of
dalzanemdor in participants with CI associated with HD. A total of 189 participants were randomized.
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The DIMENSION Study did not demonstrate a statistically significant difference from baseline in participants
treated with dalzanemdor versus placebo on the SDMT, a measure of cognitive function, at Day 84, the primary endpoint. |
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Dalzanemdor was generally well-tolerated and no new safety signals were observed. The majority of treatment
emergent adverse events were mild to moderate in severity. |
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Analyses of secondary endpoints did not demonstrate statistically significant or clinically meaningful
differences between the dalzanemdor and placebo treatment groups. |
Given these findings, the Company also will close the ongoing PURVIEW
Study, an open-label safety study of dalzanemdor in participants with HD.
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 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.