- NLS Pharmaceutics Ltd NLSP announced topline results from its Phase 2a trial evaluating its lead product candidate, Quilience (Mazindol ER), in narcolepsy.
- The trial met its primary endpoint with high statistical significance.
- Treatment with Quilience 3mg per day (NLS-2) resulted in a 7.1 point mean reduction from baseline in excessive daytime sleepiness (EDS) over the 4-week treatment period, compared to a 3.2 point reduction for placebo.
- The two treatment groups separated early and consistently throughout the study, confirming Mazindol ER's rapid onset of action and durable benefit.
- Quilience was well-tolerated, and no safety concerns were identified. No serious adverse events (SAEs) were reported. Regarding the reduction in cataplexy attacks in narcolepsy Type 1 patients (NT1), a key secondary endpoint, Quilience consistently outperformed placebo at all times.
- NLS plans to release interim results from the OLE study before year-end and announce final results in the first quarter of 2023.
- Price Action: NLSP shares are down 12.90% at $0.81 on the last check Tuesday.
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