Company: NCEL
Filing Date: 2025-09-10
Form Type: 424B3
Source: 0001213900-25-086600
Chunk: 365

Company: NewcelX Ltd.
Filing Date: 2025-09-10
Form: 424B3
Chunk 365
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 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 Population (all patients who received at least one dose of Mazindol ER). Treatment emergent adverse events (TEAEs), were reported by 48.5% (16/34) of patients receiving Mazindol ER and 23.5% (8/33) of patients receiving placebo. There were no unexpected adverse events. There were no severe and no serious TEAEs reported for either the placebo or the Mazindol ER groups. In addition, no patients discontinued Mazindol ER due to TEAEs. The most common 177 TEAEs for the Mazindol ER group was dry mouth (21.2% [7/34]) followed by nausea (9.1% [3/34]), and decreased appetite (9.1% [3/34]). The most common TEAEs for the placebo group were dry mouth (2.9% [1/34]), urinary tract infection, (2.9% [1/34]), and headache (2.9% [1/34]). Other than an expected reduction in body weight (~1.3 kg) and a moderate increase in heart rate (~11.3 bpm), there were no other significant ECG, labs, or vital signs changes on mazindol versus placebo. Patients who completed the POLARIS Phase 2 trial were able to participate in the OLE study. The OLE study enabled patients completing the randomized controlled trial to access treatment with Mazindol ER without any background stimulant and/or anti -cataplexytreatment for up to 6 months. Of the 67 patients who completed the randomized controlled Phase 2 trial, 52 patients (or