Phase II study of SAGE-324 misses goals

Sage Therapeutics’ (Nasdaq: SAGE) shares plunged nearly 22% to $10.25 in pre-market activity, as it announced disappointing top-line results from the Phase II KINETIC 2 dose-range study of the oral investigational drug SAGE-324 (BIIB124) as a potential treatment in essential tremor (ET).

Partnered with US biotech major Biogen (Nasdaq: BIIB), the 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, in participants with ET.

In addition, there were no statistically-significant differences 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, if any, for other potential indications.