Company: NCEL
Filing Date: 2025-03-03
Form Type: F-4/A
Source: 0001213900-25-018981
Chunk: 689

Company: NewcelX Ltd.
Filing Date: 2025-03-03
Form: F-4/A
Chunk 689
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psy type 1 (NT1), and therefore presented with both EDS and cataplexy symptoms. Eligible NT1 patients must have had moderate to severe disease according to the study protocol — defined as having more than 3 -4cataplexy attacks per week. Study participants were required to undergo a 1 -2-weekwash out period (depending on prior therapy). After the wash out period, participants were randomized to receive either once -dailytreatment with Mazindol ER 2mg for week 1 and 3mg for weeks 2 -4, or matching placebo for 4 weeks. For EDS, the ESS mean change from baseline to each visit and the standard error (SE) of Quilience ®(NLS -2) versus placebo were all statistically significant at week 1 -4.3 (1.13) versus -1.1 (1.06) (p=0.0055), at week 2 -4.7 (1.14) versus -1.3 (1.06) (p=0.0035), at week 3 -5.0 (1.18) versus -1.6 (1.09) (p=0.0045), and at week 4 -5.8 (1.23) versus -2.1 (1.14) ( -6.26, -1.15; p=0.0045). Annex F-49 Observed Mean Change from Baseline in ESS: The change from baseline to Week 4 in the weekly average number of cataplexy episodes decreased over time in both treatment groups. The change from Baseline to Week 4 in Average Weekly Cataplexy Episodes was statistically significantly greater in the Mazindol ER group (mean [SD] -14.3 [9.50]) than in the placebo group ( -6.1 [6.30]) (p = 0.019) despite the smaller sample size (only 1/3 of the study population were NT1 patients). Observed Mean Change from Baseline in Weekly Cataplexy Episodes: The treatment arms were balanced in terms of patient demographics, baseline levels, and disease characteristics. Mazindol ER was well -toleratedand no safety concerns were identified. No serious adverse events were reported. Mazindol ER was generally safe and well -toleratedin the completed Phase 2 trial. There were 66 patients in the Safety