Jazz hits dud note as midphase essential tremor test misses endpoint

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来源: FierceBiotech

Jazz is still evaluating the essential tremor data.

Jazz Pharmaceuticals hit a bum note Thursday, reporting the failure of a phase 2b essential tremor trial to meet its primary endpoint. But the drugmaker saw numeric improvements and is waiting on the data from another study rather than immediately bringing the curtain down on the program.

The study compared three doses of suvecaltamide, a modulator of T-type calcium channels, to placebo in 420 essential tremor patients. Essential tremor is the most common pathological movement disorder but companies have struggled to treat it, leaving physicians reliant on old drugs such as the beta blocker propranolol.

Jazz made a play for the market when it bought Cavion for $52.5 million upfront in 2019 and began the phase 2b study in 2021. The readout raises doubts about whether Jazz will generate a return on that bet.

The study found suvecaltamide was statistically no better than placebo on the TETRAS essential tremor assessment scale, causing the study to miss its primary endpoint. Jazz was left citing trends favoring the top dose, 30 mg, over placebo on the primary and key secondary endpoints as positives. The drugmaker also said that the placebo performed better than expected.

Jazz started a phase 2 trial of suvecaltamide in patients with Parkinson's disease tremor in 2022. Results from that study could seal the fate of suvecaltamide. Rob Iannone, M.D., global head of R&D at Jazz, said in a statement that the company is still evaluating the essential tremor data and will decide on the next steps after seeing the Parkinson’s results, which are due in the first quarter of next year.

Nothing is decided at this stage. Kelvin Tan, chief medical officer at Jazz, set out how the company will evaluate the data, and the importance of factors other than statistical significance, at a Goldman Sachs event last week.

“We'll look at not just statistical significance, but we'll also look at all of the other endpoints that we've collected in that trial to understand what is it that we need to determine makes clinically relevant impact, and then we'll take that into our decisions around what, hopefully, the phase 3 trial then looks like,” Tan said.

The failure is a blow, though. Jazz had identified the phase 2b as a study that could form part of a pivotal package and selected the primary endpoint because it gets “to the heart of what is it that really matters to patients, the activities of daily living, the ability to wash, to dress, to feed,” Tan said. The phase 2b trial suggests suvecaltamide is no better than placebo at improving those patient-centric outcomes.

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