- Addex Therapeutics Ltd (NASDAQ: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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