Addex Therapeutics Starts Mid-Stage Study For Dipraglurant In Parkinson's Associated Dyskinesia

  • Addex Therapeutics Ltd ADXN has started patient screening for its Phase 2b/3 study evaluating dipraglurant for dyskinesia associated with Parkinson's disease (PD-LID). 
  • Dyskinesia is believed to be caused by increased glutamatergic neurotransmission. 
  • Dipraglurant selectively targets the metabotropic glutamate receptor subtype 5, or mGlu5, to downregulate this neurotransmission through allosteric modulation.
  • Study 301, a trial of dipraglurant (100 mg tid) in 140 PD-LID patients, will evaluate efficacy in reducing PD-LID symptoms measured at week 12 compared to baseline. 
  • The company also expects to start an exploratory Phase 2 study with dipraglurant in blepharospasm patients in the coming months.
  • In Phase 2a study, dipraglurant met its primary endpoint and showed no clinically significant safety issues. 
  • In addition, on Day 1 and Day 14, dipraglurant showed statistically significant effects on PD-LID clinical symptoms.
  • However, statistical significance was not achieved at Day 28 due in part to an increasing placebo response. 
  • The registrational 301 study has an improved design incorporating multiple methods for mitigating placebo response.
  • Price Action: ADXN shares closed at $10 on Monday.
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Posted In: BiotechNewsHealth CareGeneralBriefsParkinson’s DiseasePhase 2 TrialTardive Dyskinesia
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