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Addex Spin-Out Neurosterix has started a Phase 1 Clinical Study with M4 PAM - NTX-253 for Schizophrenia

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Ad Hoc Announcement Pursuant to Art. 53 LR  Geneva, Switzerland, January 7, 2026 - Addex Therapeutic...

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AI Summary

Addex Therapeutics announced that its spinoff, Neurosterix, has initiated a Phase 1 clinical trial of NTX-253, a novel treatment for schizophrenia. This drug aims to modulate the M4 receptor for improved safety and efficacy, representing a significant milestone for both companies.

Trading Thesis

Investing in ADXN may be favorable due to potential breakthroughs in schizophrenia treatment.

Market-Moving

  • Positive Phase 1 results for NTX-253 could significantly uplift ADXN shares.
  • Market sentiment may improve with successful interim reports on NTX-253 progress.
  • Investment from Perceptive Advisors signals confidence in Neurosterix's potential.
  • Increased focus on M4 PAMs could shift treatment paradigms for schizophrenia.
  • Phase 1 study progress may attract further investment in neuropharmaceuticals.

Key Facts

  • Neurosterix started its Phase 1 clinical study on NTX-253.
  • NTX-253 is a PAM for the M4 receptor, targeting schizophrenia.
  • Addex retains a 20% equity interest in Neurosterix.
  • NTX-253 shows a favorable safety and efficacy profile in preclinical studies.
  • Neurosterix raised $65 million in a Series A financing.

Companies Mentioned

  • Addex Therapeutics (ADXN): Oversight of Neurosterix could influence ADXN share price.
  • Perceptive Advisors: Led financing for Neurosterix, indicating potential for success.

Corporate Developments

The article falls under 'Corporate Developments' as it highlights significant clinical advancements and structural changes within Addex Therapeutics and its spinoff company.

FAQ

Why Bullish?

The initiation of NTX-253's Phase 1 study could enhance investor confidence and interest. Historical parallels, such as Saama Technologies' drug development pivots, have demonstrated similar positive market reactions.

How important is it?

The announcement's focus on clinical study commencement may directly influence ADXN’s market valuation, especially if successful outcomes emerge.

Why Short Term?

The immediate impact will likely be observed if Phase 1 results provide positive data or attract further investments.

Related Companies

Addex Spin-Out Neurosterix Commences Phase 1 Clinical Study of NTX-253 for Schizophrenia

Geneva, Switzerland, January 7, 2026 - Addex Therapeutics (SIX: ADXN and Nasdaq: ADXN), a clinical-stage biopharmaceutical company specializing in small molecule allosteric modulators for neurological disorders, has announced the initiation of a Phase 1 clinical study of NTX-253 by its spin-out company, Neurosterix.

Overview of the Phase 1 Study

The Phase 1 study aims to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of NTX-253, a potent, selective, orally available positive allosteric modulator (PAM) of the muscarinic M4 receptor. This receptor is being developed to treat schizophrenia, representing a promising new direction in medication.

Significance of NTX-253 Development

Tim Dyer, CEO of Addex Therapeutics, remarked, “The progression of NTX-253 into clinical studies 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 schizophrenia a significant improvement in efficacy and safety.”

Background on Neurosterix

Neurosterix was created as a spin-out from Addex in April 2024, raising $65 million in a Series A financing round led by Perceptive Advisors. Addex Therapeutics retains a 20% equity interest in Neurosterix, indicating its ongoing commitment and involvement in this innovative venture.

The Role of M4 PAMs in Treating Schizophrenia

The M4 muscarinic receptor is a validated target for schizophrenia treatment due to its ability to indirectly modulate dopamine signaling. NTX-253 fine-tunes muscarinic signaling, potentially reducing psychotic symptoms while avoiding the adverse movement disorders and metabolic complications typical of traditional dopamine antagonists.

Key advantages of M4 PAMs include:

  • Potential for robust antipsychotic-like activity
  • A favorable safety profile based on preclinical studies
  • A reduced risk of peripheral muscarinic side effects found in direct agonists

About Addex Therapeutics

Addex Therapeutics is a pioneering clinical-stage biopharmaceutical company focused on the development of allosteric modulators for neurological disorders. Its lead candidate, dipraglurant, is under consideration for further development in brain injury recovery, and the company is progressing various candidates across multiple indications.

The company’s shares trade under the stock symbol ADXN on both the SIX Swiss Exchange and NASDAQ Capital Market. For more details, visit www.addextherapeutics.com.

Forward-Looking Statements

This press release contains forward-looking statements that are subject to risks and uncertainties, which may cause actual results to differ materially. Addex disclaims any obligation to update any forward-looking statements.

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