Published: Jun 21, 2024
By Tristan Manalac
BioSpace
Jazz Pharmaceuticals on Thursday reported that its investigational calcium channel modulator suvecaltamide missed its primary endpoint in a Phase IIb study, unable to significantly improve symptoms in patients with essential tremor.
The Dublin, Ireland-based biotech did not provide specific data in its announcement, only disclosing that the 30-mg dose of suvecaltamide “did not achieve statistical significance” versus placebo in terms of the modified composite outcome score in the Essential Tremor Rating Assessment Scale, a validated tool that quantifies tremor severity.
Suvecaltamide also did not hit its key secondary endpoint of Clinical Global Impression-Severity scale, which measures how severe patients’ symptoms are.
Jazz pointed to a greater-than-expected improvement in placebo patients, which exceeded the effects observed in a previous study of suvecaltamide.
Rob Iannone, executive vice president of global head of research and development at Jazz, in a statement said that the biotech is “disappointed” by these results. “We are evaluating the data to better understand the trial results … to determine next steps for the program.”
Despite falling short of statistical significance, Jazz touted the “numeric improvements” in tremor and overall symptom severity in patients treated with suvecaltamide.
The biotech also highlighted a strong safety and tolerability profile for suvecaltamide. The Phase IIb study found no new signals of concern, with the most common treatment-emergent adverse events being dizziness, headache, paresthesia, diarrhea and insomnia. Most side effects were mild to moderate in severity.
There was one instance of a serious adverse event, which the trial investigators deemed related to the study treatment.
Designed to be orally available, suvecaltamide is a selective and state-dependent small-molecule modulator of T-type calcium channels—which play a role in the brain’s control of muscle movement—and reduce their activity. This mechanism of action could help minimize uncontrolled movements in several neurological conditions.
Jazz is also assessing suvecaltamide in Parkinson’s disease, for which it is running a Phase II trial. The biotech enrolled the first patient in this trial in the fourth quarter of 2022.
Jazz’s neuroscience franchise has run into a rough patch in recent months. In December 2023, its post-traumatic stress disorder candidate JZP150 missed its primary endpoint in a Phase II study, failing to significantly improve symptoms versus placebo.
Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at [email protected] or [email protected].
Source: BioSpace
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