Company: NCEL
Filing Date: 2025-07-18
Form Type: F-4/A
Source: 0001213900-25-065783
Chunk: 363

Company: NewcelX Ltd.
Filing Date: 2025-07-18
Form: F-4/A
Chunk 363
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 NLS), was performed to evaluate the effectiveness and safety of mazindol in real -world, clinical practice. A total of 94 patients with narcolepsy, and suffering from cataplexy, including adults and children, with a mean 30 months of treatment exposure were included in the analysis to evaluate the effectiveness of mazindol on improving EDS. Mazindol noticeably improved EDS (p<0.0001), as measured by the ESS, a validated patient -reportedmeasure of the patients’ recent likelihood of falling asleep in everyday activities and is the same primary outcome measure widely used in other narcolepsy -relatedPhase 3 clinical trials. An analysis was also performed assessing the effectiveness of mazindol in controlling cataplexy in 62 patients and demonstrated a statistically significant reduction in the frequency of cataplexy episodes (p<0.0001). The ESS score before mazindol was 18.0 ± 3.1 and decreased to 13.6 ± 5 after mazindol, for a change of -4.2 (p<0.0001). In addition, the change in weekly cataplexy rate before and after mazindol changed from 4.6 ± 3.1 (before mazindol) to 2.0 ± 2.8 after mazindol (for a change of -2.7) (p<0.0001). 171 This retrospective study with analysis of real -worlddata, provides positive real -worldevidence that the treatment was well -toleratedand effective, in terms of improvement in EDS and the reduction in cataplexy events, with a conclusion of an overall positive benefit -riskratio in the majority of patients. In their report concluding the results of the study (Nittur et.al, Sleep Med. 2013 Jan;14(1):30 -6), the researchers found that Mazindol has a long -term, favorable benefit/risk ratio in 60% of drug -resistanthypersomniacs, including a clear benefit on cataplexy and that the data, taken altogether, suggest that mazindol has a major effect on sleepiness, possibly greater than that of modafinil (Provigil). Narcolepsy Overview and Market Opportunity Narcolepsy is the inability to stay awake and arises from the dysregulation of the sleep -wakecycle