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.
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