Sage, Biogen Shelve Development Of Nervous System Disorder Drug After Data Disappoints
Sage Therapeutics Inc. (NASDAQ:SAGE) and Biogen Inc. (NASDAQ:BIIB) announced results Wednesday from the Phase 2 KINETIC 2 dose-range study of SAGE-324 (BIIB124) as a potential treatment for essential tremor (ET).
The KINETIC 2 Study did not demonstrate a statistically significant dose-response relationship in change from baseline to Day 91 based on the primary endpoint, The Essential Tremor Rating Assessment Scale (TETRAS) Performance Subscale (PS) Item 4 (upper limb) total score.
TETRAS is used to quantify the severity of tremors and their impact on daily living activities.
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No statistically significant differences were demonstrated for any dose of SAGE-324 versus placebo in the change from baseline to Day 91 on the TETRAS PS Item 4 Total Score or the TETRAS Activities of Daily Living (ADL) Composite Score.
Given these results, Sage and Biogen will close the ongoing open-label safety study of SAGE-324 in ET and do not plan to conduct further clinical development of SAGE-324 in ET.
The companies are evaluating next steps.
In the study, 147 participants were randomized in approximately equal proportions to placebo, 15 mg, 30 mg, and 60 mg (with up-titration) for a three-month treatment period.
Overall, there was a dose-relationship observed in the incidence of CNS depressant treatment-emergent adverse events and in the frequency of TEAEs leading to study drug discontinuation.
Price Action: BIIB stock is up 0.19% at $224.71, and SAGE stock is down 16.4% at $10.94 at last check Wednesday.
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