- NLS Pharmacy Ltd NLSP announced topline results from its phase 2a study evaluating its lead product candidate Quilience (Mazindol ER) in narcolepsy.
- The study met its primary endpoint with a high level of statistical significance.
- Treatment with Quilience 3 mg per day (NLS-2) resulted in a mean reduction in excessive daytime sleepiness (EDS) of 7.1 points from baseline over the 4-week treatment period, compared with a 3.2-point reduction for placebo .
- The two treatment groups were segregated early and consistently throughout the study, confirming the rapid onset of action and lasting benefits of Mazindol ER.
- Quilience was well tolerated and no safety concerns were identified. No serious adverse events (SAE) were reported. Regarding the reduction of cataplexy attacks in patients with narcolepsy type 1 (NT1), a key secondary endpoint, Quilience outperformed placebo at all times.
- NLS plans to release interim results from the OLE study before year-end and announce final results in Q1 2023.
- Price promotion: NLSP shares are down 12.90% to $0.81 on the latest check Tuesday.
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