Company: NCEL
Filing Date: 2025-07-29
Form Type: F-4/A
Source: 0001213900-25-068765
Chunk: 371

Company: NewcelX Ltd.
Filing Date: 2025-07-29
Form: F-4/A
Chunk 371
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 POLARIS study were eligible to participate in an open label extension (OLE) study and continued once -a-daytreatment with Mazindol ER 3 mg for up to six months as monotherapy (no concomitant wake -promotingor anti -cataplexytreatments were allowed). On January 30, 2023, NLS announced that 87% of patients who completed the POLARIS Phase 2 study requested to continue monotherapy treatment with Mazindol ER in the six -monthOLE study rather than transition to other therapies. In September 2022, NLS announced top -linedata relating to its Phase 2 POLARIS study for the use of Mazindol ER in patients with narcolepsy. Of the 60 patients targeted for enrollment in the U.S. Phase 2 trial (Study NLS -1021), 67 were randomized and included in the final analysis. The final database included 33 patients on treatment and 34 patients on placebo, with balanced mean baseline ESS scores (17.9 for treatment and 18.0 for placebo). Approximately one -thirdof patients enrolled in the study were diagnosed with narcolepsy 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. 176 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.