After Disappointing Parkinson's Data, Sage Therapeutics' Dalzanemdor Flunks Mid-Stage Alzheimer's Study

Tuesday, Sage Therapeutics, Inc. SAGE released topline results from the Phase 2 LIGHTWAVE 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 study’s primary outcome measure.

The WAIS-IV test assesses the intellectual abilities of people aged between 16 and 90. A total of 174 participants were randomized.

Based on these data, the company does not plan further clinical development of dalzanemdor in Alzheimer’s. 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.

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 Repeatable Battery for Assessment of Neuropsychological Status (RBANS) and the Montreal Cognitive Assessment (MoCA), both cognitive tests.

Earlier this year, PRECEDENT Phase 2 study of dalzanemdor in people with mild cognitive impairment in Parkinson’s Disease also failed to meet its primary endpoint.

In September, Sage Therapeutics announced that Biogen Inc BIIB terminated its rights under the collaboration and license agreement with Sage, which was specific to the SAGE-324 program.

The companies recently announced negative results from the Phase 2 KINETIC 2 Study of investigational SAGE-324 for the chronic treatment of essential tremor (ET) and discontinued further clinical development of SAGE-324 in ET.

Price Action: At last check on Tuesday, SAGE stock was down 11.30% at $5.96 during the premarket session.

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