Biogen, Sage Phase 2 meets primary endpoint

 Statistically significant reduction in tremor score compared to placebo at Day 29 in adults with essential tremor

SAGE-324 demonstrated a 36% reduction in upper limb tremor amplitude from baseline at Day 29 in the total studied population; in a more severe population (baseline TETRAS Upper Limb Item 4 >12), SAGE-324 demonstrated a 41% reduction in upper limb tremor amplitude compared to baseline

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

Sage Therapeutics to host conference call today at 8 a.m. ET

Sage Therapeutics, Inc. (Nasdaq: SAGE) and Biogen Inc. (Nasdaq: BIIB) today reported topline results from the Phase 2 KINETIC Study evaluating SAGE-324 in the treatment of people with essential tremor (ET). The study (n=67 full analysis set) achieved its primary endpoint of a statistically significant reduction from baseline compared to placebo in The Essential Tremor Rating Assessment Scale (TETRAS) Performance Subscale Item 4 upper limb tremor score on Day 29 (P=0.049), which corresponded to a 36% reduction from baseline in upper limb tremor amplitude in patients receiving SAGE-324 compared to a 21% reduction in patients receiving placebo. Activities of daily living (ADL) scores showed a statistically significant correlation with upper limb tremor score at all timepoints. While not powered to fully examine TETRAS ADL, SAGE-324 was numerically superior to placebo at all time points. Reported treatment-emergent adverse events (TEAEs) were generally consistent with the safety profile of SAGE-324 to date.

In the KINETIC Study, patients (n=47) with a more severe tremor at baseline (at or above the median TETRAS Performance Subscale upper limb tremor Item 4 score of 12) who received SAGE-324, demonstrated a statistically significant reduction (P=0.007) 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. Study patients were not taking other medications for ET during the 28-day treatment period.

Sage will host a conference call and webcast today, Monday, April 12, at 8:00 a.m. ET to discuss the KINETIC Study topline results. The live webcast can be accessed on the investor page of Sage's website at investor.sagerx.com. A replay of the webcast will be available on Sage's website approximately two hours after the completion of the event and will be archived for up to 30 days.

https://finance.yahoo.com/news/sage-therapeutics-biogen-announce-sage-110000150.html