Company: NCEL
Filing Date: 2025-03-03
Form Type: F-4/A
Source: 0001213900-25-018981
Chunk: 674

Company: NewcelX Ltd.
Filing Date: 2025-03-03
Form: F-4/A
Chunk 674
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 moderate improvement in narcolepsy symptoms and their respective side effects may limit their use. The AASM specifically highlights that future investigations should be directed toward development of more effective and better tolerated therapies and primary prevention. The Voice of the Patient report from the FDA’s patient -focuseddrug development initiative, published in 2014, concluded that, based on the overall benefit -riskassessment of currently approved medications, there is a continued need for additional effective and tolerable treatment options for patients with narcolepsy. A retrospective analysis (Nittur et.al, Sleep Med. 2013 Jan;14(1):30 -6) showed that mazindol has a long -term, favorable benefit/risk ratio in 60% of drug -resistanthypersomniacs, including a clear benefit on the two primary symptoms of narcolepsy, EDS and cataplexy. • Quilience is expected to have minimal drug interactions.Based on the results of five in vitro metabolism studies, Mazindol ER has a very low potential for drug interactions In the lab, mazindol did not interact with any of the enzymes that metabolize drugs in humans. Its metabolism was also not influenced by any well -knownenzyme inhibitors or stimulants. One of its metabolites (representing less than 12% of mazindol) showed some interactions with a minor metabolic enzyme named P -glycoprotein(Pgp) and this interaction will be further investigated in humans. Nevertheless, mazindol showed significantly less interactions with metabolic enzymes than any other narcolepsy treatment. Annex F-41 • Quilience is being developed as a once -daily oral tablet administered in the morning upon wakening. Patients have identified a need for treatment options that are easier to take, dosed less frequently, do not disrupt night -timesleeping and provide full day coverage of symptoms. We believe that once -dailydosing with Quilience may address this need and may help improve patient compliance and adherence with treatment. Quilience utilizes our proprietary extended -releaseformulation and is being designed to optimize its pharmacokinetic and pharmacodynamic properties with a rapid onset of action and prolonged controlled therapeutic effect, allowing for a daily oral dose that effectively provides consistent and long -actingsymptom control to uniquely meet the needs of patients. Leveraging our scientific insights and direct hands -onclinical experience, we are developing compounds that we believe have innovative mechanisms of action with positive therapeutic profiles and represent a differentiated treatment option to overcome