Jazz Pharmaceuticals said Thursday that the highest dose of suvecaltamide failed a Phase 2b trial in essential tremor, a neurological condition that causes involuntary shaking.
Patients who took a 30 mg dose of suvecaltamide did not achieve a statistically significant change from baseline compared to placebo on a scale designed to measure the severity of essential tremor. While the treatment group saw a numeric improvement compared to placebo over 12 weeks, Jazz also said the placebo group saw improvements that “exceeded the company’s expectations.”
The company’s stock $JAZZ was down more than 4% on Thursday morning.
A Jazz spokesperson said the company plans to share full results, including data for the two lower doses — 10 mg and 20 mg — that were also studied in the essential tremor study.
Rob Iannone“We are evaluating the data to better understand the trial results and await the results of the suvecaltamide trial in Parkinson’s disease tremor to determine next steps for the program,” Jazz’s global head of R&D Rob Iannone said in a news release.
The Phase 2 results in Parkinson’s disease tremor are anticipated in the first quarter of 2025.
Jazz snagged suvecaltamide in its 2019 buyout of the neurological disease biotech Cavion. The drug is designed to modulate T-type calcium channels, which affect the brain’s control of muscle movement. Jazz once hoped Phase 2 results in essential tremor could be taken to regulators.
“If trial findings are positive, we believe this trial could serve as part of the pivotal regulatory package,” Iannone said in May during the company’s first-quarter earnings call, according to an AlphaSense transcript.
Jazz’s neuroscience pipeline is largely focused on sleep disorders, including narcolepsy. The company’s Xywav, a lower-sodium alternative to its prior blockbuster Xyrem, was approved in 2020 to treat adults with narcolepsy and again the following year for idiopathic hypersomnia.