Jazz Pharma Updates Phase 2b Trial of Suvecaltamide (JZP385) in Essential Tremor

DUBLIN, June 20, 2024—Jazz Pharmaceuticals plc (Nasdaq: JAZZ) has reported results from its Phase 2b clinical trial (NCT05122650) assessing the effectiveness and safety of suvecaltamide (JZP385), a selective modulator of T-type calcium channels, in treating adults with essential tremor (ET). The drug did not achieve statistically significant improvement at a 30mg dosage compared to a placebo on the primary measure, which was the change from baseline to week 12 on the Essential Tremor Rating Assessment Scale (TETRAS) modified composite outcome score. Similar results were noted on the key secondary measure, the Clinical Global Impression-Severity (CGI-S) scale.

Despite the lack of statistical significance, there were numeric improvements on both the primary and secondary endpoints for the 30mg dose compared to the placebo. However, the placebo group's improvement from baseline to week 12 surpassed expectations and exceeded results from the previous T-CALM trial involving suvecaltamide.

Rob Iannone, M.D., M.S.C.E., Executive Vice President and Global Head of Research and Development at Jazz Pharmaceuticals, expressed disappointment with the trial's failure to meet its primary endpoint. He emphasized the substantial unmet needs of people living with ET and extended gratitude to the trial participants, their families, and the investigators. Iannone also mentioned that the data is being analyzed to better understand the trial outcomes, and they await results from a suvecaltamide trial in Parkinson's disease tremor, expected in the first quarter of 2025.

Suvecaltamide demonstrated good tolerance, with its safety profile aligning with previous studies. Common adverse events included dizziness, headache, paresthesia, diarrhea, and insomnia, mostly mild to moderate in severity. One participant reported a serious treatment-related adverse event.

The Phase 2b trial was a 12-week, multicenter, double-blind, randomized, placebo-controlled study. It evaluated the efficacy and safety of suvecaltamide with once-daily oral doses of 10, 20, and 30mg, compared to a placebo. The primary endpoint was a modified TETRAS composite outcome score, combining items from TETRAS-ADL and TETRAS-PS with scoring modifications. The key secondary endpoint measured the percentage of participants with at least a one-point improvement on the CGI-S scale. The trial involved 420 participants across four countries.

Suvecaltamide (JZP385) is being investigated as a highly selective and state-dependent modulator of T-type calcium channels, which are important for muscle movement regulation in the brain. The drug binds preferentially to stabilize a specific conformation of the channel, thereby reducing its activity. An ongoing Phase 2 proof-of-concept trial is also investigating suvecaltamide for Parkinson's disease tremor (NCT05642442).

Jazz Pharmaceuticals plc, based in Dublin, Ireland, is committed to developing innovative treatments for serious diseases, often where few or no therapeutic options exist. The company's diverse portfolio includes therapies for sleep disorders, epilepsy, and cancer. Jazz Pharmaceuticals emphasizes a patient-focused, science-driven approach to research and development. The company operates globally, with research and development laboratories, manufacturing facilities, and a workforce dedicated to improving patient outcomes.

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