Company: NCEL
Filing Date: 2025-03-03
Form Type: F-4/A
Source: 0001213900-25-018981
Chunk: 681

Company: NewcelX Ltd.
Filing Date: 2025-03-03
Form: F-4/A
Chunk 681
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 of symptom control, variable efficacy, rebound sleepiness and rebound cataplexy, troublesome side effects, inconvenience, and high potential for abuse. Given the considerable burden of the condition, the adverse effects on the health of narcolepsy patients, and the limitations of available medications, there is a critical unmet need for additional treatment options. Quilience is a triple monoamine reuptake inhibitor, a SNDRI and partial agonist of the OX2R that may mimic the natural sleep -wakeprocess by activating and further enhancing the brain mechanisms that promote and regulate wakefulness. We believe Quilience may bridge this considerable treatment gap and that the current narcolepsy landscape may provide an opportunity to establish ourselves as a leader in this space. Real-World Evidence in Narcolepsy The use of real -worldevidence may improve the quality and efficiency of clinical development and clinical trial design, with the potential to accelerate the development of therapies that may provide meaningful benefits to patients. Real -worldevidence is the analysis of real -worlddata, which can originate from sources such as CUPs, and may provide a more complete picture of patient experience to inform patient -focuseddrug development, and support the advancement of randomized, placebo -controlledclinical trials to support a marketing application. While no longer commercially available in the United States or Europe, the active molecule in Quilience, mazindol, was previously widely used off -labeland for several decades for the treatment of narcolepsy. Additionally, it was prescribed under a long -termCUP administered and regulated by ANSM (“L’agence nationale de sécurité du medicament et des produits de santé”), the national agency in France responsible for overseeing the safety of medicines and health products, helping to address the unmet needs of patients who did not initially respond, later failed or were unable to tolerate the approved available treatments, such as modafinil, methylphenidate, sodium oxybate, and amphetamine -basedproducts. This CUP ran for 17 years, ended in 2016 due to unavailability of the product, and more than 200 patients with narcolepsy who were refractory to available treatments were prescribed mazindol for the treatment of EDS and/or cataplexy. A retrospective, multi -center, observational study of this real -worlddata, financed by the French Health Ministry, and conducted in part by certain members of our team and members of our Scientific Advisory Board (prior to their work with us