ADXN · Addex Therapeutics Ltd

Addex Therapeutics announced that its spin-out company, Neurosterix, is on track to complete its Phase 1 clinical study of NTX-253, a muscarinic M4 receptor positive allosteric modulator for schizophrenia, in the second quarter of 2026. The study is designed to generate a comprehensive early-stage clinical data package assessing safety, tolerability, and pharmacokinetics in both healthy volunteers and patients with stable schizophrenia. The multi-part design includes single ascending dose (SAD) and multiple ascending dose (MAD) components, with food-effect and cerebrospinal fluid assessments to evaluate CNS exposure. The inclusion of patient cohorts in the MAD phase represents early clinical evaluation in the target population, with antipsychotic medication withdrawal for up to eight days prior to dosing. Neurosterix was spun out of Addex in April 2024 with $65 million in Series A financing led by Perceptive Advisors, and Addex retains a 20% equity interest. This update is significant for investors as it indicates progress in the development of a novel treatment for schizophrenia, a large unmet medical need, and highlights the potential value of Addex's stake in Neurosterix.