Addex Therapeutics (SIX: ADXN and Nasdaq: ADXN), a clinical-stage biopharmaceutical company focused on developing a portfolio of novel small molecule allosteric modulators for neurological disorders, today announced that its spin-out company, Neurosterix, is on track to complete its Phase 1 clinical study evaluating NTX-253 in Q2 2026. NTX-253 is an investigational potent, selective, orally available positive allosteric modulator (PAM) of the muscarinic M4 receptor being developed for the treatment of schizophrenia. The study is designed to generate a robust early-stage clinical data package assessing safety, tolerability, and pharmacokinetics (PK) across both healthy adult participants and those with stable schizophrenia.
The clinical study includes a multi-part, ascending-dose design intended to efficiently characterize NTX-253’s clinical profile and support subsequent patient-focused development. The study includes both single ascending dose (SAD) and multiple ascending dose (MAD) components, incorporating key translational elements such as food-effect and cerebrospinal fluid (CSF) assessments.
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