SAGE Therapeutics (NASDAQ:SAGE) stock price dropped significantly pre-market Wednesday after the company, alongside partner Biogen, announced disappointing results from a late-stage clinical trial for its drug SAGE-324 (BIIB124) for essential tremor (ET).
The Phase 2 KINETIC 2 study failed to meet its primary endpoint, which measured improvement in upper limb tremors. Additionally, no statistically significant difference was observed between any dosage of SAGE-324 and a placebo on other key tremor assessments.
Sage shares are currently down more than 19%, trading below the $11 per share mark.
"We are disappointed that the results of the KINETIC 2 Study do not support further development of SAGE-324 in ET," said Dr. Laura Gault, Chief Medical Officer at Sage Therapeutics. The company, along with Biogen, will halt the ongoing open-label safety study and discontinue further development of SAGE-324 for essential tremor.
Katherine Dawson, Head of the Therapeutics Development Unit, at Biogen said: "We believe that the findings add to the collective understanding of this debilitating condition and may help inform the field on potential future research and therapeutic approaches."
Essential tremor is a neurological disorder causing uncontrollable shaking, primarily affecting the hands. With limited treatment options available, the unmet medical need for ET patients is significant.
This failed trial is a setback for both Sage and Biogen, and investors reacted swiftly with the pre-market stock price decline.
Both companies are evaluating potential next steps for SAGE-324 in other treatment areas.