ADX71149 / Addex - LARVOL DELTA

A Study to Investigate JNJ-40411813 in Combination With Levetiracetam or Brivaracetam in Epilepsy (clinicaltrials.gov) - P2 | N=110 | Completed | Sponsor: Janssen Research & Development, LLC | Active, not recruiting ➔ Completed

Combination therapy • Trial completion • CNS Disorders • Epilepsy

A Study to Investigate JNJ-40411813 in Combination With Levetiracetam or Brivaracetam in Epilepsy (clinicaltrials.gov) - P2 | N=110 | Active, not recruiting | Sponsor: Janssen Research & Development, LLC | Recruiting ➔ Active, not recruiting

Combination therapy • Enrollment closed • CNS Disorders • Epilepsy

A Study to Investigate JNJ-40411813 in Combination With Levetiracetam or Brivaracetam in Epilepsy (clinicaltrials.gov) - P2 | N=110 | Recruiting | Sponsor: Janssen Research & Development, LLC | N=160 ➔ 110

Combination therapy • Enrollment change • CNS Disorders • Epilepsy

A Study to Investigate JNJ-40411813 in Combination With Levetiracetam or Brivaracetam in Epilepsy (clinicaltrials.gov) - P2 | N=160 | Recruiting | Sponsor: Janssen Research & Development, LLC | Trial completion date: Apr 2026 ➔ Apr 2024

Combination therapy • Trial completion date • CNS Disorders • Epilepsy

Addex mGlu2 NAM Cognition Program Receives €4 Million Grant (GlobeNewswire) - " Addex Therapeutics...announced that it has led a consortium which has been awarded a €4 million Eurostars grant to support its metabotropic glutamate 2 (mGlu2) receptor negative allosteric modulator (NAM) program for mild neurocognitive disorder (mNCD). The project, named COGNI+, has been awarded the grant to deliver clinical candidates ready for IND enabling studies. The consortium includes Naason Science (South Korea), BioAxis Research (Netherlands), Pharmidex Pharmaceutical Services (UK) and Stichting Radboud Universiteit (Netherlands)....'As a reminder, our ADX71149 epilepsy program is on track to report Phase 2 data in Q2 2024 and we continue to make solid progress toward achieving other strategic objectives, including securing industry partners for certain programs."

Financing • P2 data • Alzheimer's Disease • CNS Disorders • Epilepsy • Parkinson's Disease

Addex Reports Full Year 2022 Financial Results and Provides Corporate Update (GlobeNewswire) - "ADX71149 epilepsy Phase 2 study part 1 completed with Independent interim review committee recommendation expected early Q2 2023."

Trial status • Epilepsy • Parkinson's Disease

Addex Strategic Partner Completes Enrollment in ADX71149 Epilepsy Phase 2 Study Part 1 (GlobeNewswire) - "Addex Therapeutics...announced that enrollment into Part 1 of the Phase 2 clinical study of ADX71149 (JNJ-40411813) for the treatment of epilepsy has been completed. ADX71149 is a selective metabotropic glutamate type 2 (mGlu2) receptor positive allosteric modulator (PAM). The trial is being conducted by Janssen Pharmaceuticals, Inc., part of the Janssen Pharmaceutical Companies of Johnson & Johnson. Data from Part 1 will now be evaluated by an independent interim review committee (IRC) to ensure the study remains blinded. Based on the outcome of this review and recommendations from the IRC, Janssen will evaluate next steps for the program."

Enrollment status • CNS Disorders • Epilepsy

ADDEX PROVIDES CORPORATE UPDATE AND FINANCIAL GUIDANCE (Addex Pharmaceuticals Press Release) - "ADX71149, our mGlu2 PAM, licensed to Janssen Pharmaceuticals Inc., a Johnson and Johnson company: continues to advance in a Phase 2 study in epilepsy patients with completion of part 1 on track for Q1 2023. Under our agreement with Janssen, we are eligible to receive up to €109 million in success-based development and regulatory milestone, and low double-digit royalties on net sales."

Commercial • Trial status • CNS Disorders • Epilepsy

Addex and Indivior Extend Research Term of Substance Use Disorder GABAB Positive Allosteric Modulator Discovery Collaboration (Yahoo Finance) - "'In addition to the progress made with Indivior, we anticipate a decision by Janssen in Q1 2023 on moving ADX71149 further into clinical development based on results from the first part of a Phase 2 study in epilepsy.'"

Clinical • CNS Disorders • Epilepsy

Addex Reports Q3 2022 Financial Results and Provides Corporate Update (GlobeNewswire) - "Janssen led ADX71149 Phase 2 study in epilepsy on track to complete part 1 in Q1 2023."

Trial status • CNS Disorders • Epilepsy

Current and future pharmacotherapy options for drug-resistant epilepsy. (PubMed, Expert Opin Pharmacother) - "Current pharmacotherapy options for drug-resistant epilepsy include perampanel, brivaracetam and the newly approved cenobamate for focal epilepsies; cannabidiol (Epidiolex) for Lennox-Gastaut Syndrome (LGS), Dravet and Tuberous Sclerosis Complex (TSC); fenfluramine for Dravet syndrome and ganaxolone for seizures in Cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder...For adult focal epilepsies, padsevonil and carisbamate are at a more advanced Phase III stage of clinical development followed by compounds at Phase II like selurampanel, XEN1101 and JNJ-40411813. For specific epilepsy syndromes, XEN 496 is under Phase III development for potassium voltage-gated channel subfamily Q member 2 developmental and epileptic encephalopathy (KCNQ2-DEE), carisbamate is under Phase III development for LGS and Ganaxolone under Phase III development for TSC. Finally, in preclinical models several molecular targets including inhibition of glycolysis, neuroinflammation and sodium..."

Journal • CNS Disorders • Epilepsy • Genetic Disorders • Immunology • Inflammation

A Study to Investigate JNJ-40411813 in Combination With Levetiracetam or Brivaracetam in Epilepsy (clinicaltrials.gov) - P2 | N=160 | Recruiting | Sponsor: Janssen Research & Development, LLC | Trial completion date: Apr 2024 ➔ Apr 2026

Combination therapy • Trial completion date • CNS Disorders • Epilepsy

Clinical investigations of compounds targeting metabotropic glutamate receptors. (PubMed, Pharmacol Biochem Behav) - "PET ligands for mGlu5Rs have been studied in a range of patient populations and several mGlu5R antagonists have been tested for potential efficacy in patients including mavoglurant, diploglurant, basimglurant, GET 73, and ADX10059...Fenobam was approved for use as an anxiolytic prior to its recognition as an mGlu5R antagonist. mGlu2/3R agonists (pomaglumated methionil) and mGlu2R agonists (JNJ-40411813, AZD 8529, and LY2979165) have been studied in patients with schizophrenia with promising but mixed results. Antagonists of mGlu2/3Rs (decoglurant and TS-161) have been studied in depression where TS-161 has advanced into a planned Phase 2 study in treatment-resistant depression...The mGlu4R potentiator, foliglurax, did not meet its primary endpoint in patients with Parkinson's disease. Ongoing efforts to develop mGluR-targeted compounds continue to promise these glutamate modulators as medicines for psychiatric and neurological disorders."

Journal • CNS Disorders • Depression • Developmental Disorders • Epilepsy • Fragile X Syndrome • Gastroenterology • Gastroesophageal Reflux Disease • Genetic Disorders • Mental Retardation • Mood Disorders • Movement Disorders • Pain • Parkinson's Disease • Psychiatry • Schizophrenia

Addex Reports 2022 Half Year and Second Quarter Financial Results and Provides Corporate Update (GlobeNewswire) - "Addex Therapeutics...reported its half-year and second quarter financial results for the periods ended June 30, 2022 and provided a corporate update....H2 2022 Operating Highlights: ADX71149 epilepsy Phase 2 study on track to report data in Q1 2023."

P2 data • CNS Disorders • Epilepsy

Addex Reports Q1 2022 Financial Results (BioSpace) - "Janssen led ADX71149 Phase 2 study in epilepsy expected to report data in Q4 2022."

P2 data • CNS Disorders • Epilepsy

Epilepsy: Expert opinion on emerging drugs in phase 2/3 clinical trials. (PubMed, Expert Opin Emerg Drugs) - "Novel mechanisms of action involve cholesterol degradation, mitochondrial pathways, anti-inflammation and neuro-regeneration. Earlier identification of genetic conditions through genetic testing will allow for earlier use of disease specific and disease-modifying therapies."

Journal • P2/3 data • CNS Disorders • Epilepsy • Immunology • Inflammation

Addex Provides Year End Pipeline Development Update (Yahoo Finance) - "ADX71149: Our partner, Janssen Pharmaceuticals, Inc., part of the Janssen Pharmaceutical Companies of Johnson & Johnson, is progressing well with a Phase 2a clinical study of ADX71149 in epilepsy patients. Data from this study is expected during Q3 2022. Recently, we announced that Phase 1 studies in Japan had been successfully completed, allowing Japan to be included in a potential future global development program."

P2a data • CNS Disorders • Epilepsy

Addex Strategic Partner Successfully Completes Phase 1 in Japan with ADX71149 (GlobeNewswire) - "Addex Therapeutics...announced that Janssen Pharmaceuticals, Inc., part of the Janssen Pharmaceutical Companies of Johnson & Johnson, has successfully completed Phase 1 studies in Japan with JNJ-40411813 (ADX71149)...The successful completion of this Phase 1 safety program will enable centers in Japan to be included in a potential global development of ADX71149 for the treatment of epilepsy...'The ongoing study of ADX71149 in epilepsy patients is on track to deliver interim results in Q3 2022, which will guide future development.'"

P2 data • Trial completion • CNS Disorders • Epilepsy

Addex Reports Q3 2021 Financial Results and Provides Corporate Update (GlobeNewswire) - "Addex Therapeutics...today reported its Q3 2021 financial results for the periods ended September 30, 2021 and provided a corporate update...Q3 22 - Phase 2a data: ADX71149 for epilepsy. Q4 22 - Phase 2b/3 data: dipraglurant for dyskinesia associated with Parkinson’s disease."

P2/3 data • P2a data • CNS Disorders • Parkinson's Disease

Addex to Present at the 10th International Meeting on Metabotropic Glutamate Receptors (GlobeNewswire) - "Addex Therapeutics...announced today that Dr Lütjens...will discuss the discovery and development of ADX71149, the mGlu2 positive allosteric modulator discovered in collaboration with Janssen Pharmaceuticals Inc., part of the Janssen Pharmaceutical Companies of Johnson & Johnson, currently in a phase 2a study in epilepsy patients."

Clinical • CNS Disorders • Epilepsy

Addex Therapeutics Initiates Phase 2 Clinical Study with Dipraglurant in Blepharospasm (GlobeNewswire) - "'We are now poised for a significant year of reporting data in 2022...top-line data from our pivotal study of dipraglurant in levodopa induced dyskinesia in Parkinson’s and for ADX71149 in epilepsy later in 2022.'"

Clinical data • CNS Disorders • Epilepsy • Parkinson's Disease

Addex Starts Phase 2 Clinical Study of ADX71149 for Epilepsy (GlobeNewswire) - "Addex Therapeutics...announced that the first patients have been enrolled into a Phase 2 clinical study evaluating JNJ-40411813 (ADX71149) in patients with epilepsy. JNJ-40411813 (ADX71149) is a selective metabotropic glutamate type 2 (mGlu2) receptor positive allosteric modulator (PAM). The trial is being conducted in collaboration with Janssen Pharmaceuticals, Inc., part of the Janssen Pharmaceutical Companies of Johnson & Johnson....'Data from the study are expected in Q3 2022...'"

P2 data • Trial status • CNS Disorders • Epilepsy

Addex, Stanford University and University of Copenhagen Publish mGlu2 Structure in Nature Using Addex Allosteric Modulators (GlobeNewswire) - "Addex existing mGlu2 positive allosteric modulator, ADX71149, in clinical studies for epilepsy and mGlu2 negative allosteric modulators in preclinical development for neurocognitive disorders...The Nature publication explains how the mGlu2 receptor undergoes profound conformational transitions from an inactive to an active state."

Preclinical • CNS Disorders • Epilepsy

A Study of JNJ-40411813 in Healthy Japanese Male Participants (clinicaltrials.gov) - P1; N=39; Completed; Sponsor: Janssen Pharmaceutical K.K.; Recruiting ➔ Completed

Clinical • Trial completion

Addex Reports Q1 2021 Financial Results and Provides Corporate Update (GlobeNewswire) - "Select Upcoming Milestones:...Q2 21 - Phase 2a study starting: ADX71149 for epilepsy; partnered with Janssen...Q3 22 - Phase 2a data: ADX71149 for epilepsy."

New P2a trial • P2a data • CNS Disorders • Epilepsy