– In the Phase 2 LIGHTWAVE Study, dalzanemdor (SAGE-718) did not demonstrate a statistically significant difference from baseline in participants treated with dalzanemdor versus placebo on the primary endpoint
– Dalzanemdor was generally well-tolerated and no new safety signals were observed
– Topline data from the Phase 2 DIMENSION Study of dalzanemdor in Huntington’s Disease expected later this year
CAMBRIDGE, MA, USA I October 08, 2024 I Sage Therapeutics, Inc. (Nasdaq: SAGE) announced today topline results from LIGHTWAVE, a 12-week, Phase 2 randomized, double-blind, placebo-controlled study to evaluate the effects of dalzanemdor (SAGE-718) in participants with mild cognitive impairment (MCI) or mild dementia due to Alzheimer’s Disease (AD). The LIGHTWAVE Study did not demonstrate a statistically significant difference from baseline in participants treated with dalzanemdor versus placebo on the Wechsler Adult Intelligence Scale Fourth Edition (WAIS-IV) Coding Test score at Day 84, the primary outcome measure of the study.
Based on these data, the Company does not plan further clinical development of dalzanemdor in AD. The Company expects to report topline data from the Phase 2 DIMENSION Study of dalzanemdor in people with cognitive impairment associated with Huntington’s Disease later this year.
“Alzheimer’s Disease is an incredibly complex and devastating condition, and people with related mild cognitive impairment and mild dementia need more treatment options. While we are disappointed by the results of the LIGHTWAVE Study, we are grateful to participants, investigators, care partners, patient advocates and the Alzheimer’s community who helped make this important research possible. We hope our work and these findings help to inform future research,” said Barry Greene, Chief Executive Officer, Sage Therapeutics.
LIGHTWAVE Study Results
The LIGHTWAVE study was a 12-week, Phase 2 randomized, double-blind, placebo-controlled study to evaluate the effects of dalzanemdor in participants with MCI or mild dementia due to AD. A total of 174 participants were randomized.
- The LIGHTWAVE study did not demonstrate a statistically significant difference from baseline in participants treated with dalzanemdor versus placebo on the WAIS-IV Coding Test score at Day 84.
- 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.
- Analyses did not demonstrate any meaningful differences in the dalzanemdor-treated group versus placebo in exploratory endpoints such as RBANS total score or MoCA total score.
About dalzanemdor (SAGE-718)
Dalzanemdor (SAGE-718) is a first-in-class investigational NMDA receptor positive allosteric modulator (PAM). Sage has an ongoing placebo-controlled Phase 2 study evaluating dalzanemdor in cognitive impairment associated with Huntington’s Disease.
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.
SOURCE: Sage Therapeutics
Post Views: 3,242
– In the Phase 2 LIGHTWAVE Study, dalzanemdor (SAGE-718) did not demonstrate a statistically significant difference from baseline in participants treated with dalzanemdor versus placebo on the primary endpoint
– Dalzanemdor was generally well-tolerated and no new safety signals were observed
– Topline data from the Phase 2 DIMENSION Study of dalzanemdor in Huntington’s Disease expected later this year
CAMBRIDGE, MA, USA I October 08, 2024 I Sage Therapeutics, Inc. (Nasdaq: SAGE) announced today topline results from LIGHTWAVE, a 12-week, Phase 2 randomized, double-blind, placebo-controlled study to evaluate the effects of dalzanemdor (SAGE-718) in participants with mild cognitive impairment (MCI) or mild dementia due to Alzheimer’s Disease (AD). The LIGHTWAVE Study did not demonstrate a statistically significant difference from baseline in participants treated with dalzanemdor versus placebo on the Wechsler Adult Intelligence Scale Fourth Edition (WAIS-IV) Coding Test score at Day 84, the primary outcome measure of the study.
Based on these data, the Company does not plan further clinical development of dalzanemdor in AD. The Company expects to report topline data from the Phase 2 DIMENSION Study of dalzanemdor in people with cognitive impairment associated with Huntington’s Disease later this year.
“Alzheimer’s Disease is an incredibly complex and devastating condition, and people with related mild cognitive impairment and mild dementia need more treatment options. While we are disappointed by the results of the LIGHTWAVE Study, we are grateful to participants, investigators, care partners, patient advocates and the Alzheimer’s community who helped make this important research possible. We hope our work and these findings help to inform future research,” said Barry Greene, Chief Executive Officer, Sage Therapeutics.
LIGHTWAVE Study Results
The LIGHTWAVE study was a 12-week, Phase 2 randomized, double-blind, placebo-controlled study to evaluate the effects of dalzanemdor in participants with MCI or mild dementia due to AD. A total of 174 participants were randomized.
- The LIGHTWAVE study did not demonstrate a statistically significant difference from baseline in participants treated with dalzanemdor versus placebo on the WAIS-IV Coding Test score at Day 84.
- 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.
- Analyses did not demonstrate any meaningful differences in the dalzanemdor-treated group versus placebo in exploratory endpoints such as RBANS total score or MoCA total score.
About dalzanemdor (SAGE-718)
Dalzanemdor (SAGE-718) is a first-in-class investigational NMDA receptor positive allosteric modulator (PAM). Sage has an ongoing placebo-controlled Phase 2 study evaluating dalzanemdor in cognitive impairment associated with Huntington’s Disease.
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.
SOURCE: Sage Therapeutics
Post Views: 3,242
