Jazz Pharmaceuticals’ suvecaltamide has failed to meet primary or key secondary endpoints in a Phase IIb essential tremor (ET) trial.
The Dublin, Ireland-based biopharma company announced top-line results from the multi-centre, double-blind trial (NCT05122650) evaluating the efficacy and safety of once-daily oral suvecaltamide in 420 patients.
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The high-dose cohort (30mg) failed to achieve the primary endpoint of change from baseline to week 12 on the Essential Tremor Rating Assessment Scale (TETRAS) and the key secondary endpoint of the Clinical Global Impression-Severity (CGI-S) scale. Data for the 10mg or 20mg cohorts has not yet been released.
Although the data did not reach statistical significance, Jazz said there were numeric improvements observed on the primary endpoint and key secondary endpoint. There was also a more significant increase in improvement in the placebo cohort than expected, higher than that of the previous T-CALM trial (NCT03101241).
Executive vice-president of Jazz Pharmaceuticals Rob Iannone said: “We are disappointed that the trial did not meet its primary endpoint. We recognise the significant unmet need for people living with ET. 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 the next steps for the programme.”
Iannone added that results for the ongoing Phase II Parkinson’s disease tremor trial (NCT05642442) are expected in the first quarter of 2025.
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By GlobalDataThe candidate remained well tolerated with no new safety signals observed. One participant experienced a serious adverse event (AE), which was considered treatment-related by the investigator.
Suvecaltamide is an investigational, highly selective and state-dependent modulator of T-type calcium channels (Cav3), which play a role in the brain’s control of muscle movement. Suvecaltamide preferentially binds to stabilise a specific conformation of the channel and reduce activity.
Jazz Therapeutics got hold of the candidate during a $312.5m acquisition of Cavion in August 2019.
GlobalData predicts global sales of the candidate to reach $470m in 2030.
GlobalData is the parent company of Clinical Trials Arena.
ET landscape
ET is a neurological disorder that causes involuntary and rhythmic shaking. It is one of the most common trembling disorders and is often confused with Parkinson’s disease.
According to a report by GlobalData, published in 2023, the current treatment landscape for ET includes just 11 therapies, all of which are genericised.
The most common treatments are beta-blockers including propranolol, and anticonvulsants such as primidone are used as Level A treatments and are considered the most effective. Other beta-blockers like arotinolol and benzodiazepines, such as diazepam, are used as Level B and Level C treatment options for ET and considered to be less effective.
The pipeline is also considered to be sparse in ET, with just one agent, Praxis Precision Medicines’ ulixacaltamide hydrochloride, being investigated in a Phase III trial (NCT06087276). Sage Therapeutics’ SAGE-324 is being investigated in a Phase II/III long-term safety and tolerability trial (NCT05366751). All other agents are in Phase II or lower.
