Cavion planning Phase III for essential tremor candidate despite Phase II miss

Cavion Inc. (Charlottesville, Va.) said CX-8998 missed the primary endpoint in the Phase II T-CALM trial to treat moderate to severe essential tremor. Despite the miss, the company plans to start a Phase III trial by 4Q19 of the compound in the indication that will use a different primary endpoint than that of the Phase II trial. CX-8998 is a calcium channel T-type blocker.

On the Phase II trial's primary endpoint, CX-8998 failed to improve tremor severity from baseline to day 28 measured using remote video rating of the Tremor Research Group Essential Tremor Rating Assessment Scale - Performance Subscale (TETRAS-PS) vs. placebo (p=0.696). However, in-person investigator ratings of TETRAS-PS did show a significant improvement in tremor severity at day 28 vs. placebo (p=0.027). According to the company, an independent analysis of the video rating process uncovered "unexpected complications in implementation."...