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
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Should l Buy ADXN?
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 Participants in these cohorts will have their antipsychotic medications withdrawn for up to eight days prior to dosing with NTX-253, enabling assessment of safety and PK in patients while maintaining clinical stability.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.
Addex Therapeutics Reports FY 2025 Net Loss
- Financial Decline: Addex Therapeutics reported a net loss of CHF 6.7 million for FY 2025, contrasting sharply with a net profit of CHF 7.1 million in 2024, indicating a significant deterioration in profitability that may undermine investor confidence.
- Revenue Source Changes: While specific revenue sources for 2025 were not disclosed, the reported loss suggests potential challenges in product sales or research progress, which could adversely affect future cash inflows.
- Market Reaction Expectations: Given the poor financial performance, Addex's stock price may experience negative pressure, prompting investors to closely monitor the company's future strategic adjustments and profit recovery plans.
- Need for Strategic Reevaluation: In light of ongoing financial losses, Addex may need to reassess its R&D pipeline and market strategies to ensure sustainable growth in the highly competitive biopharmaceutical industry.
See More
Addex Therapeutics Reports 2025 Financial Results and Strategic Developments
- R&D Progress: Addex Therapeutics' GABAB PAM chronic cough candidate demonstrated robust anti-tussive activity across multiple disease models, indicating its potential for clinical application and possibly opening new revenue streams for the company.
- Strategic Collaboration: The exclusive licensing agreement with Sinntaxis aims to leverage mGlu5 NAM for brain injury recovery, further enhancing Addex's competitive edge in the neurological disorder treatment space.
- Financial Position: As of December 31, 2025, cash reserves stood at CHF 1.6 million, significantly down from 2024, reflecting the company's cash burn in R&D and investment activities, which may impact future operational flexibility.
- Loss Overview: The net loss for 2025 reached CHF 6.7 million, a stark contrast to a net profit of CHF 7.1 million in 2024, primarily due to reduced revenues from the Neurosterix transaction, highlighting financial pressures on the company.
See More
Addex Reports Promising Preclinical Data for Chronic Cough Treatment
- Promising Preclinical Data: Addex Therapeutics announced that its GABAB positive allosteric modulator demonstrated significant antitussive activity in a bleomycin-induced idiopathic pulmonary fibrosis chronic cough model, indicating potential for improving patient quality of life.
- Efficacy and Safety Profile: In studies involving non-human primates, the compound exhibited robust antitussive efficacy without significant changes in respiratory rate or body temperature throughout the treatment, supporting its safety for chronic administration.
- Improved Lung Pathology: Compared to untreated animals, the treatment group showed significant reductions in Ashcroft scores and affected lung tissue percentages at both Day 7 and Day 28, indicating a positive impact on fibrosis and further validating its clinical application prospects.
- Strong Market Demand: Chronic cough remains a significant unmet medical need among patients with idiopathic pulmonary fibrosis, and Addex's research findings could provide new treatment options in this area, enhancing its competitive position in the market.
See More
Addex Therapeutics Advances NTX-253 Phase 1 Trial for Schizophrenia
- Clinical Trial Progress: Addex Therapeutics announced that the Phase 1 trial for NTX-253 targeting schizophrenia is expected to conclude by Q2 2026, demonstrating the company's ongoing commitment to mental health research and development.
- Drug Mechanism: NTX-253 is a potent, selective, orally available positive allosteric modulator that reduces psychotic symptoms by modulating dopamine signaling while avoiding movement disorders associated with other dopamine antagonists, potentially enhancing its market competitiveness.
- Trial Design: The Phase 1 trial consists of single ascending dose (SAD) and multiple ascending dose (MAD) parts, with the SAD part evaluating the impact of food on NTX-253 pharmacokinetics, while the MAD part assesses safety and tolerability in schizophrenia patients, ensuring clinical application safety.
- Equity Structure: Addex retains a 20% equity interest in Neurosterix, which is advancing a portfolio of allosteric modulator programs for schizophrenia, psychosis, and mood-related disorders, indicating Addex's strategic positioning in the mental health sector.
See More
Addex Therapeutics Announces Progress on NTX-253 Clinical Study
- Clinical Study Progress: Addex Therapeutics' spin-out Neurosterix is on track to complete its Phase 1 clinical study of NTX-253, targeting schizophrenia, by Q2 2026, focusing on safety and pharmacokinetics.
- Innovative Study Design: The study features a multi-part, ascending-dose design that integrates data from both healthy adults and stable schizophrenia patients, aiming to efficiently characterize NTX-253's clinical profile and mitigate risks for subsequent studies.
- Mechanism of Action Advantage: NTX-253, as a selective positive allosteric modulator, may reduce psychotic symptoms by indirectly modulating dopamine signaling while avoiding the movement disorders and metabolic complications associated with traditional dopamine antagonists, demonstrating a favorable safety profile.
- Financing Background: Neurosterix was spun out from Addex in April 2024, raising $65 million in funding, with Addex retaining a 20% equity stake, reflecting confidence in its future development prospects.
See More
Addex's Novel GABAB PAM Shows Strong Efficacy in Chronic Cough Model
- Significant Drug Efficacy: Addex Therapeutics' novel GABAB positive allosteric modulator demonstrated robust anti-tussive activity in a non-human primate chronic cough model, significantly reducing citric acid-induced cough frequency with efficacy comparable to baclofen, but with fewer side effects, indicating a wider therapeutic margin and improved tolerability.
- Supporting Preclinical Research: Previous studies in guinea pigs also showed reductions in cough frequency and increased cough latency without signs of tolerance after repeated dosing, further validating the candidate's potential in chronic cough treatment.
- Importance of Therapeutic Context: Chronic cough is a challenging condition with limited approved therapies, and Addex's PAM aims to deliver the therapeutic benefits of baclofen while enhancing selectivity, tolerability, and durability by targeting an allosteric site of the GABAB receptor, which holds significant clinical implications.
- Optimistic Company Outlook: CEO Tim Dyer emphasized that the new primate data, combined with prior preclinical findings, supports the therapeutic potential of the GABAB PAM program, indicating that the company is expanding its portfolio of small-molecule allosteric modulators for neurological and psychiatric disorders.
See More
Addex Therapeutics Reports FY 2025 Net Loss
- Financial Decline: Addex Therapeutics reported a net loss of CHF 6.7 million for FY 2025, contrasting sharply with a net profit of CHF 7.1 million in 2024, indicating a significant deterioration in profitability that may undermine investor confidence.
- Revenue Source Changes: While specific revenue sources for 2025 were not disclosed, the reported loss suggests potential challenges in product sales or research progress, which could adversely affect future cash inflows.
- Market Reaction Expectations: Given the poor financial performance, Addex's stock price may experience negative pressure, prompting investors to closely monitor the company's future strategic adjustments and profit recovery plans.
- Need for Strategic Reevaluation: In light of ongoing financial losses, Addex may need to reassess its R&D pipeline and market strategies to ensure sustainable growth in the highly competitive biopharmaceutical industry.
See More
Addex Therapeutics Reports 2025 Financial Results and Strategic Developments
- R&D Progress: Addex Therapeutics' GABAB PAM chronic cough candidate demonstrated robust anti-tussive activity across multiple disease models, indicating its potential for clinical application and possibly opening new revenue streams for the company.
- Strategic Collaboration: The exclusive licensing agreement with Sinntaxis aims to leverage mGlu5 NAM for brain injury recovery, further enhancing Addex's competitive edge in the neurological disorder treatment space.
- Financial Position: As of December 31, 2025, cash reserves stood at CHF 1.6 million, significantly down from 2024, reflecting the company's cash burn in R&D and investment activities, which may impact future operational flexibility.
- Loss Overview: The net loss for 2025 reached CHF 6.7 million, a stark contrast to a net profit of CHF 7.1 million in 2024, primarily due to reduced revenues from the Neurosterix transaction, highlighting financial pressures on the company.
See More
Addex Reports Promising Preclinical Data for Chronic Cough Treatment
- Promising Preclinical Data: Addex Therapeutics announced that its GABAB positive allosteric modulator demonstrated significant antitussive activity in a bleomycin-induced idiopathic pulmonary fibrosis chronic cough model, indicating potential for improving patient quality of life.
- Efficacy and Safety Profile: In studies involving non-human primates, the compound exhibited robust antitussive efficacy without significant changes in respiratory rate or body temperature throughout the treatment, supporting its safety for chronic administration.
- Improved Lung Pathology: Compared to untreated animals, the treatment group showed significant reductions in Ashcroft scores and affected lung tissue percentages at both Day 7 and Day 28, indicating a positive impact on fibrosis and further validating its clinical application prospects.
- Strong Market Demand: Chronic cough remains a significant unmet medical need among patients with idiopathic pulmonary fibrosis, and Addex's research findings could provide new treatment options in this area, enhancing its competitive position in the market.
See More
Addex Therapeutics Advances NTX-253 Phase 1 Trial for Schizophrenia
- Clinical Trial Progress: Addex Therapeutics announced that the Phase 1 trial for NTX-253 targeting schizophrenia is expected to conclude by Q2 2026, demonstrating the company's ongoing commitment to mental health research and development.
- Drug Mechanism: NTX-253 is a potent, selective, orally available positive allosteric modulator that reduces psychotic symptoms by modulating dopamine signaling while avoiding movement disorders associated with other dopamine antagonists, potentially enhancing its market competitiveness.
- Trial Design: The Phase 1 trial consists of single ascending dose (SAD) and multiple ascending dose (MAD) parts, with the SAD part evaluating the impact of food on NTX-253 pharmacokinetics, while the MAD part assesses safety and tolerability in schizophrenia patients, ensuring clinical application safety.
- Equity Structure: Addex retains a 20% equity interest in Neurosterix, which is advancing a portfolio of allosteric modulator programs for schizophrenia, psychosis, and mood-related disorders, indicating Addex's strategic positioning in the mental health sector.
See More
Addex Therapeutics Announces Progress on NTX-253 Clinical Study
- Clinical Study Progress: Addex Therapeutics' spin-out Neurosterix is on track to complete its Phase 1 clinical study of NTX-253, targeting schizophrenia, by Q2 2026, focusing on safety and pharmacokinetics.
- Innovative Study Design: The study features a multi-part, ascending-dose design that integrates data from both healthy adults and stable schizophrenia patients, aiming to efficiently characterize NTX-253's clinical profile and mitigate risks for subsequent studies.
- Mechanism of Action Advantage: NTX-253, as a selective positive allosteric modulator, may reduce psychotic symptoms by indirectly modulating dopamine signaling while avoiding the movement disorders and metabolic complications associated with traditional dopamine antagonists, demonstrating a favorable safety profile.
- Financing Background: Neurosterix was spun out from Addex in April 2024, raising $65 million in funding, with Addex retaining a 20% equity stake, reflecting confidence in its future development prospects.
See More
Addex's Novel GABAB PAM Shows Strong Efficacy in Chronic Cough Model
- Significant Drug Efficacy: Addex Therapeutics' novel GABAB positive allosteric modulator demonstrated robust anti-tussive activity in a non-human primate chronic cough model, significantly reducing citric acid-induced cough frequency with efficacy comparable to baclofen, but with fewer side effects, indicating a wider therapeutic margin and improved tolerability.
- Supporting Preclinical Research: Previous studies in guinea pigs also showed reductions in cough frequency and increased cough latency without signs of tolerance after repeated dosing, further validating the candidate's potential in chronic cough treatment.
- Importance of Therapeutic Context: Chronic cough is a challenging condition with limited approved therapies, and Addex's PAM aims to deliver the therapeutic benefits of baclofen while enhancing selectivity, tolerability, and durability by targeting an allosteric site of the GABAB receptor, which holds significant clinical implications.
- Optimistic Company Outlook: CEO Tim Dyer emphasized that the new primate data, combined with prior preclinical findings, supports the therapeutic potential of the GABAB PAM program, indicating that the company is expanding its portfolio of small-molecule allosteric modulators for neurological and psychiatric disorders.
See More
