Benzinga | Jun 29, 2021 08:59AM EDT

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

* 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.