Jazz's Tremor Drug Fails Phase II Trial

Jazz Pharmaceuticals has announced that its investigational drug, suvecaltamide, did not meet the primary endpoint in a Phase IIb clinical trial for essential tremor. The biotech company, headquartered in Dublin, Ireland, shared that the 30-mg dose of suvecaltamide failed to show significant improvement over a placebo in the modified composite outcome score of the Essential Tremor Rating Assessment Scale. This scale is a validated measure used to quantify the severity of tremors.

In addition to missing the primary endpoint, suvecaltamide also did not meet the key secondary endpoint, which involved the Clinical Global Impression-Severity scale. This scale assesses the severity of patients’ symptoms. Jazz Pharmaceuticals suggested that an unexpected improvement in the placebo group played a role in the trial's outcome, surpassing the effects seen in an earlier study of suvecaltamide.

Rob Iannone, the executive vice president and global head of research and development at Jazz, expressed disappointment over the trial results. He mentioned that the company is currently analyzing the data to understand the outcomes better and to determine the next steps for the program.

Despite not achieving statistical significance, Jazz highlighted some numeric improvements in tremor and overall symptom severity for patients treated with suvecaltamide. The company also emphasized the drug's safety and tolerability profile. The Phase IIb study did not identify any new safety concerns. The most common side effects reported were dizziness, headache, paresthesia, diarrhea, and insomnia, most of which were mild to moderate in severity. There was one instance of a serious adverse event, which was considered related to the study treatment by the trial investigators.

Suvecaltamide is designed to be an orally available, selective, and state-dependent small-molecule modulator of T-type calcium channels. These channels are involved in the brain's control of muscle movement. By reducing their activity, suvecaltamide aims to minimize uncontrolled movements associated with various neurological conditions.

Jazz Pharmaceuticals is also examining the potential of suvecaltamide in treating Parkinson’s disease. A Phase II trial for this indication is already underway, with the first patient enrolled in the fourth quarter of 2022.

Recently, Jazz’s neuroscience division has faced several challenges. In December 2023, another one of its candidates, JZP150, failed to meet its primary endpoint in a Phase II study for post-traumatic stress disorder (PTSD), showing no significant improvement in symptoms compared to a placebo.