Jazz posts results for XYWAV sleep study; registers new zanidatamab real-world study

Two Jazz Pharmaceuticals studies moved this week, one with new results and one newly registered.

• Jazz completed and posted results for a Phase 4 study of low-sodium oxybate oral solution (XYWAV) evaluating sleepiness, polysomnography, and functional outcomes in adults aged 18 to 75 with idiopathic hypersomnia or narcolepsy.¹ The trial enrolled 199 participants and used a single-arm, open-label design where participants titrated to an optimal XYWAV dosage.¹ The primary outcome was change from baseline in Epworth Sleepiness Scale (ESS) total score, measured from baseline up to end of treatment at approximately 10 to 36 weeks.¹
• Jazz registered a new observational study, "ZOLA," to collect real-world data describing the effectiveness and tolerability of first line zanidatamab-containing therapies in participants with unresectable, locally advanced, recurrent or metastatic HER2-positive gastroesophageal adenocarcinoma.² The study is not yet recruiting and plans to enroll 300 participants who initiate zanidatamab-containing therapy as first line treatment as part of standard-of-care treatment.²