- Swiss biopharma NLS Pharmaceutics AG ( NASDAQ: NLSP ) slipped ~17% pre-market Tuesday despite announcing positive topline data from a Phase 2a clinical trial for lead candidate Quilience involving patients with sleep disorder narcolepsy.
- The 67-patient trial was designed to evaluate the once-daily monotherapy, also known as Mazindol ER, as a treatment for excessive daytime sleepiness (EDS) and cataplexy in narcolepsy.
- The multi-center study reached the primary endpoint over a 4-week treatment period as Quilience led to a 7.1-point mean reduction in EDS from baseline in terms of a clinical measure called the Epworth Sleepiness Scale compared to the 3.2-point decline in the placebo group.
- The study drug outperformed the placebo across all time points in relation to a decline in cataplexy attacks in narcolepsy Type 1 patients, a key secondary endpoint of the study.
- Quilience was found to be well tolerated with no serious adverse events or safety concerns, the company said.
- NLSB plans to share interim data from the open-label extension of the study before year-end and final data in Q1 2023.
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NLS Pharma falls 17% despite positive Phase 2 data for narcolepsy candidate