NLS Pharmaceutics announces in-vitro data on Quilience

NLS Pharmaceutics announced new in vitro study results demonstrating the agonist effect of mazindol ER at the Orexin-2 Receptor. Two identical studies measuring differing concentrations of mazindol ER confirmed significant OX2R partial agonist activity at 30muM or higher. Notably, findings show that mazindol ER showed strong OX2R partial agonist activity by cellular and nuclear receptor functional assays. Results showed pEC50 values of 4.7 to 5 for mazindol on the OX2R, indicating a strong OX2R partial agonist. Orexin, also known as hypocretin, is a neuropeptide that regulates arousal, wakefulness, and appetite. Orexin plays a critical role in regulating the sleep-wake cycle and the most common form of narcolepsy, type 1, in which the individual experiences brief losses of muscle tone, known as or cataplexy, is caused by a lack of orexin in the brain due to destruction of the cells that produce it. Mazindol ER is an OX2R partial agonist that was developed to address the loss of orexin signaling in NT1. Currently available treatments for NT1 only address the associated symptoms but not the underlying loss of orexin. Additional pre-clinical in vivo studies are currently underway to confirm OX2R activity. A pilot study in OXR2 KO mice animal model compared favorably with investigational drug, TAK-925, an orexin 2 receptor agonist. Supplementary studies to further characterize OX2R activity as well as activity at OX1R are planned for the first half of 2023. NLS Pharmaceutics plans to present the study results at a scientific meeting later this year. The Phase 3 program for Quilience is currently on track to commence in mid- 2023.