0578 Clinician and Patient Global Impression in a Phase 2 Study of Mazindol (NLS-1021) in Adults with Narcolepsy Type 1 and Type 2

Abstract Introduction Mazindol is the first partial orexin 2 receptor agonist and triple monoamine reuptake inhibitor in development for treatment of narcolepsy. Clinician Patient Global Impression (CGI PGI, respectively) cataplexy excessive daytime sleepiness were assessed as secondary endpoints phase (POLARIS, NLS-1021) multicenter study mazindol ER adult participants with narcolepsy type 1 (NT1) or (NT2) (ClinicalTrials.gov Identifier: NCT04923594). Methods Adults diagnosed NT1 NT2 who washed out medications at baseline included into study. Patients treated (NLS-2) once-daily mg one week 3 thereafter matching placebo (PBO) on a 1:1 ratio. Throughout study, CGI Severity (CGI-S) PGI (PGI-S) severity sleepiness, respectively, compared scores baseline. Both scales have five levels severity: “None”, “Mild”, “Moderate”, “Severe”, “Very Severe.” Results Sixty-seven randomized (NT1 33.3% NLS-2 group; 35.3% PBO). At baseline, mean CGI-S – Cataplexy was approximately 3.7 Sleepiness 3.4. Despite small sample size, end double-blind (DB) period, group demonstrated clinically statistically significant improvements vs. PBO both (d = –0.7, p 0.016) –0.8, 0.020). PGI-S 3.2 3.7. DB 0.007) 0.023). Conclusion resulted conditions rated by clinicians participants. These outcome results support efficacy attacks, participants, well Support (if any) NLS Pharmaceutics