Addex Therapeutics Ltd. (ADXN), a clinical-stage biopharmaceutical company, announced on Wednesday that the Phase 1 trial for NTX-253 in treating schizophrenia, developed by spun-out company Neurosterix, is on track to conclude by the second quarter of 2026.
NTX-253 is an investigational, potent, selective, orally-available positive allosteric modulator (PAM) of the muscarinic M4 receptor. By modulating dopamine signaling, the drug can reduce psychotic symptoms while avoiding the movement disorders associated with other dopamine antagonists.
The Phase 1 trial consists of two parts, namely a single ascending dose (SAD) part and multiple ascending dose (MAD) part.
The Part 1 SAD study will dose healthy participants with a single oral dose of NTX-253 in sequentially-escalating dose cohorts. The study will evaluate the impact of food on NTX-253 pharmacokinetics, and measure the drug's concentration in cerebrospinal fluid (CSF) to assess brain penetration. In contrast, the Part 2 MAD study will also dose two cohorts of schizophrenia patients, and will evaluate the safety, tolerability, and steady state pharmacokinetics with repeated doses. Participants will receive a daily oral-dosing with sequential dose escalation over 10 days.
Addex retains a 20% equity interest in Neurosterix, which is advancing a portfolio of allosteric modulator programs for schizophrenia, psychosis and mood-related disorders.
ADXN closed Wednesday at $6.60, down 6.12%. In the premarket, shares are trading at $6.88, down 4.24%.
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