Addex Therapeutics' Spin-Out Neurosterix to Complete NTX-253 Clinical Study in Q2
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Apr 23 2026
0mins
Addex Therapeutics announced that its spin-out company, Neurosterix, is on track to complete its Phase 1 clinical study evaluating NTX-253 in Q2. NTX-253 is an investigational potent, selective, orally available positive allosteric modulator of the muscarinic M4 receptor being developed for the treatment of schizophrenia. The study is designed to generate an early-stage clinical data package assessing safety, tolerability, and pharmacokinetics 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 and multiple ascending dose components, incorporating key translational elements such as food-effect and cerebrospinal fluid assessments. Healthy adult participants will receive a single oral dose of NTX-253 or placebo across sequentially escalating dose cohorts. This phase includes a dedicated food-effect cohort to assess the impact of food on NTX-253 pharmacokinetics. A separate SAD cohort in healthy volunteers will evaluate NTX-253 concentrations in cerebrospinal fluid, providing early insight into central nervous system exposure and brain penetration. In the MAD phase, participants will receive once-daily oral dosing of NTX-253 or placebo for 10 consecutive days, with sequential dose escalation. This phase is designed to evaluate safety, tolerability, and steady-state pharmacokinetics following repeated dosing. The MAD phase includes two dedicated cohorts of adults with stable schizophrenia, representing early clinical evaluation in the target patient population. Participants in these cohorts will have their antipsychotic medications withdrawn for up to eight days prior to dosing with NTX-253, enabling assessment of safety and PK in patients while maintaining clinical stability. Neurosterix was spun-out of Addex in April 2024, raising $65M in a Series A financing led by funds affiliated with Perceptive Advisors. Addex retains a 20% equity interest in Neurosterix.
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About ADXN
Addex Therapeutics Ltd is a Switzerland-based clinical-stage pharmaceutical company. The Company focuses on development and commercialization of orally available small molecule drugs known as allosteric modulators for neurological disorders. The Company’s clinical programs pipeline include dipraglurant (mGlu5 NAM), which is Phase 2a placebo-controlled clinical trial for Parkinson's disease levodopa-induced dyskinesia (PD-LID), and is being prepared to enter registration trials for PD-LID, and ADX71149 (mGlu2 positive allosteric modulator or PAM), which is being developed in collaboration by its partner Janssen Pharmaceuticals, Inc to treat schizophrenia and anxious depression. It also is advancing several preclinical programs, including GABABPAM for pain, overactive bladder and other disorders, mGlu7 NAM for post-traumatic stress disorder, mGlu2 NAM for mild neurocognitive disorders, mGlu4 PAM for Parkinson’s disease and mGlu3 PAM for neurodegenerative disorders.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
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- Sleep Pattern Changes: The study revealed that ADX71743 increased wakefulness while reducing both REM and non-REM sleep in rats, indicating its potential application in sleep regulation.
- Neurotransmitter Modulation: The drug altered stress-induced changes in neurotransmitters such as glutamate, GABA, and monoamines across multiple brain regions, showcasing its role in modulating stress-responsive neural circuits, which may provide new insights for treating related disorders.
- Future Development Focus: Addex continues to advance its portfolio of small-molecule allosteric modulators, particularly the dipraglurant and GABAB PAM programs targeting neurological disorders, highlighting the company's ongoing innovation and investment in the neuroscience field.
See More
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- Research Publication: Addex Therapeutics announced new findings demonstrating that ADX71743, a selective negative allosteric modulator, significantly modulates sleep-wake regulation and stress-related neurochemistry in animal models, further validating its therapeutic potential in neurological disorders.
- Mechanism Validation: The study indicates that ADX71743 increases wakefulness while reducing both REM and non-REM sleep in rats, highlighting its crucial role in modulating stress-responsive neural circuits, which may open new avenues for treating anxiety and mood disorders.
- Scientific Basis Strengthened: The results, published in the International Journal of Neuropsychopharmacology, bolster the evidence for mGlu7 as a vital therapeutic target for various central nervous system disorders, enhancing Addex's scientific foundation in this field.
- Future Development Prospects: CEO Tim Dyer noted that the findings of ADX71743 provide strong scientific rationale for Neurosterix's ongoing development, indicating the drug's broad application potential in addressing anxiety, sleep regulation, and related conditions.
See More
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- Financial Report Approval: Shareholders approved the annual report and financial statements for 2025, which not only ensures financial transparency but also lays the groundwork for future capital operations.
- Board Re-elections: Key board members, including Dr. Vincent Lawton and Dr. Raymond Hill, were re-elected, ensuring continuity and stability in corporate governance, which is crucial for achieving the company's strategic objectives.
- Capital Structure Amendments: The approval of amendments to the Articles of Association regarding the increase of the capital band and conditional share capital will provide greater flexibility for future financing and expansion efforts.
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- Increased Net Loss: The company reported a net loss of CHF1.7 million in Q1 2026, up from CHF1.5 million in the same period of 2025, primarily due to its share of losses from Neurosterix, highlighting escalating financial pressures.
- Positive R&D Progress: Despite financial challenges, Addex has made significant strides in its GABAB positive modulator program, demonstrating robust antitussive activity in preclinical models, potentially laying the groundwork for future clinical applications.
- Undervalued Equity: Addex retains a 20% equity stake in Neurosterix, which is currently undervalued in the market; however, this stake could provide additional financial support for Addex as Neurosterix advances into clinical stages.
See More
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- Historical Financial Data: Historical earnings data shows significant volatility in Addex's profitability, reflecting ongoing investments in R&D and marketing that could lead to increased financial pressure in the short term.
- Market Reaction: The market's response to this earnings report may influence Addex's stock price trajectory, particularly as the company has yet to achieve profitability, leading to cautious investor expectations for future growth.
- Future Outlook: Despite the current poor financial performance, Addex's efforts in developing new therapies may lay the groundwork for future revenue growth, making it essential for investors to monitor subsequent developments.
See More
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- Significant Revenue Drop: The company's Q1 revenue plummeted to CHF 8,000 from CHF 71,000 a year ago, highlighting substantial challenges in product sales and market penetration, which could adversely affect future cash flow and operational sustainability.
- Reduced R&D Spending: Research and development expenses decreased from CHF 0.16 million to CHF 0.04 million, which, while cutting costs, may hinder the progress of new drug developments, particularly in the increasingly competitive field of neurological treatments.
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