Neurosterix announces the success of a Phase I trial for NTX-253
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The drug candidate, intended for the treatment of schizophrenia, is now set to enter Phase II. Addex holds a 20 per cent stake in the Plan-les-Ouates-based pharmaceutical company.
Addex Therapeutics (SIX: ADXN and Nasdaq: ADXN), a clinical-stage biopharmaceutical company based in Geneva and focused on developing a portfolio of novel small molecule allosteric modulators for neurological disorders, announced that its spin-out company, Neurosterix, in which Addex holds a 20% equity interest, has completed its Phase 1 clinical studies evaluating NTX-253 and plans to advance NTX-253 into Phase 2 clinical development. NTX-253 is a positive allosteric modulator (PAM) of the muscarinic M4 receptor being developed for the treatment of schizophrenia.
“Completing Phase 1 and the decision by Neurosterix to progress NTX-253 into Phase 2 studies in schizophrenia patients is a significant achievement,” said Tim Dyer, CEO of Addex. “The well-designed study combining healthy volunteers and schizophrenia patients within a single study has provided important safety and pharmacokinetic data.”
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. The studies included both healthy volunteers and stable schizophrenia patients, and has provided important safety and pharmacokinetic data.
Neurosterix was spun-out of Addex in April 2024, raising $65 million in a Series A financing led by funds affiliated with Perceptive Advisors. Addex retains a 20% equity interest in Neurosterix.
About NTX-253 and M4 PAMs
The M4 muscarinic receptor is a validated target for treating schizophrenia and related disorders through indirect modulation of dopamine signaling. NTX-253 is a potent, selective, oral PAM of M4 that fine-tunes muscarinic signaling with the potential to reduce psychosis symptoms while avoiding the movement disorders and metabolic complications associated with traditional dopamine antagonists. Preclinical studies demonstrate robust antipsychotic-like activity and a favorable safety profile.
➡️ Source: Press Release