- NLS Pharmaceutics Ltd (NASDAQ:NLSP) has announced interim topline data from its Phase 2a trial of its lead product candidate, Quilience (Mazindol ER), in narcolepsy.
- For excessive daytime sleepiness (EDS), the trial's primary endpoint, patients on Mazindol ER exhibited a mean decrease of 7.3 points on the sleepiness scale compared to a 3.0 point decrease for patients on placebo.
- Patients on Mazindol ER showed a mean 39% improvement on the sleepiness scale from baseline.
- To date, Mazindol ER was generally safe and well-tolerated in the current Phase 2a trial, and the interim data are consistent with prior mazindol studies.
- Related: NLS Pharma Stock Gains After Issuance Of Mazindol US Patent.
- No patients dropped out of the study due to safety or efficacy concerns, and only one patient in the interim analysis discontinued the study for personal reasons.
- Study NLS-1022 (OLE study) to access treatment with Mazindol ER treatment for up to 6 months.
- As of the data collection date for the Phase 2a interim analysis (February 25, 2022), 82% of patients who completed the randomized controlled study elected to participate in the OLE study.
- Price Action: NLSP shares are down 32.70% at $1.19 during the market session on the last check Wednesday.
