Jazz Pharmaceuticals plc announced top-line results from the Phase 2b clinical trial (NCT05122650) evaluating the efficacy and safety of suvecaltamide (JZP385), an investigational, highly selective and state-dependent modulator of T-type calcium channels, in adult patients with essential tremor (ET). Suvecaltamide did not achieve statistical significance at 30mg versus placebo on the primary endpoint of change from baseline to week 12 on the Essential Tremor Rating Assessment Scale (TETRAS) modified composite outcome score and key secondary endpoint of Clinical Global Impression-Severity (CGI-S) scale. While not statistically significant, numeric improvements were observed on the primary endpoint and key secondary endpoint at 30mg versus placebo.

The improvement in placebo from baseline to week 12 also exceeded the Company's expectations and was higher than what was observed for placebo in the prior T-CALM trial of suvecaltamide. Suvecaltamide was well tolerated and the overall safety profile was consistent with previous studies with no new safety signals observed. The most common treatment-emergent adverse events (TEAEs) were dizziness, headache, paresthesia, diarrhea and insomnia.

These were predominately mild to moderate in severity. One participant experienced a serious adverse event considered treatment related by the investigator. The Phase 2b clinical trial (NCT05122650) is a 12-week, multicenter, double-blind, randomized, placebo-controlled trial evaluating the efficacy and safety ofsuvecaltamide in a once-daily oral dose of 10, 20 and 30mg or placebo.

The primary endpoint (modified TETRAS composite outcome score) represents items 1-11 from the TETRAS-ADL combined with items 6+7 (spiral and handwriting assessments, respectively) from the TETRAS -PS with scoring modifications. The key secondary endpoint in the trial measured the percentage of participants with 1 point improvement on CGI-S. The trial randomized 420 participants from four countries. Suvecaltamide (JZ P385) is an investigational, highly selective, state-dependent modulator ofT-type calcium channels (Cav3).

T-type calcium channels play a role in the brain's control of muscle movement.1 Suvecaltamide preferentially binds to stabilize a specific conformation of the channel and reduce activity. The suvecaltamide Phase 2 proof-of-concept trial in Parkinson's disease tremor is ongoing (NCT05642442).