Neurosterix, the spin‑out of Addex Therapeutics, began a Phase 1 clinical trial of NTX‑253 on January 7 2026. The study will enroll healthy volunteers to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of NTX‑253, a potent, selective muscarinic M4 receptor positive allosteric modulator (PAM) designed to fine‑tune dopamine signaling without the motor and metabolic side effects that accompany traditional antipsychotics.
The spin‑out, completed in April 2024, was backed by a $65 million Series A round led by Perceptive Advisors, and Addex retains a 20 % equity stake in Neurosterix. The funding and corporate structure give Neurosterix dedicated resources to advance its neurological portfolio while allowing Addex to focus on its broader pipeline.
Addex Therapeutics, however, is facing significant financial headwinds. Recent reports show a 71.3 % decline in three‑year revenue growth, an operating margin of –7,753 % and a net margin of –19,053 %. These negative margins and shrinking top line raise questions about the parent company’s ability to support its stake in Neurosterix and fund future development activities.
Tim Dyer, CEO of Addex, said the trial “represents an important milestone for both Neurosterix and Addex. Selective modulation of the M4 receptor through a PAM offers a novel therapeutic approach that could provide patients with a differentiated efficacy and safety profile.” The statement underscores the strategic intent to differentiate from conventional dopamine antagonists and signals confidence in the scientific rationale behind NTX‑253.
The initiation of the Phase 1 study positions Neurosterix within a competitive landscape that includes other M4 PAM candidates such as AbbVie’s Emraclidine. Successful safety and pharmacodynamic data could accelerate the company’s development timeline and enhance its attractiveness to investors and potential partners, while also providing a potential revenue stream for Addex if the program progresses to later‑stage trials.
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