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Sage Therapeutics : Phase 2 Study Of SAGE-324 In Essential Tremor Meets Primary Endpoint

Sage Therapeutics Inc. (SAGE) and Biogen Inc. (BIIB) said that phase 2 KINETIC Study, which evaluated SAGE-324 in the treatment of people with essential tremor, achieved its primary endpoint of a statistically significant reduction from baseline compared to placebo in The Essential Tremor Rating Assessment Scale or TETRAS Performance Subscale Item 4 upper limb tremor score on Day 29.

SAGE-324 demonstrated a safety profile generally consistent with previously reported data.

SAGE-324 demonstrated a 36% reduction in upper limb tremor amplitude from baseline at Day 29 in the total studied population, compared to a 21% reduction in patients receiving placebo.

The study, patients with a more severe tremor at baseline who received SAGE-324, demonstrated a statistically significant reduction from baseline in TETRAS Performance Subscale Item 4 upper limb tremor score compared to placebo at Day 29, corresponding to a 41% reduction from baseline in upper limb tremor amplitude in patients receiving SAGE-324 compared to an 18% reduction for placebo.

SAGE-324 is an investigational oral neuroactive steroid (NAS) GABAA receptor positive allosteric modulator. NAS GABAA receptor PAMs bind to both synaptic and extrasynaptic GABAA receptors, enhancing inhibitory activity of the GABAergic system, the major inhibitory neurotransmission system in the brain.

In November 2020, Biogen and Sage Therapeutics said they entered into a global collaboration and license agreement to jointly develop and commercialize zuranolone (SAGE-217) for major depressive disorder, postpartum depression and other psychiatric disorders, and SAGE-324 for essential tremor and other neurological disorders.

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