Dipraglurant (Immediate Release), for the treatment of levodopa-induced dyskinesia associated with Parkinson’s disease (PD-LID).
We are developing dipraglurant as a novel orally available mGlu5 NAM for the treatment of PD-LID. PD-LID is an indication with significant commercial opportunities as improved therapies are needed.
We believe that dipraglurant may be a first-in-class oral drug candidate for PD-LID and may offer an innovative and differentiated treatment approach from existing therapies. In a Phase 2a clinical trial conducted in the United States and Europe in patients with PD-LID, dipraglurant demonstrated statistically significant and clinically meaningful effects on clinical symptoms.
We have substantially completed the preparation of dipraglurant to start registration studies in PD-LID and expect to initiate a Phase 2b/3 placebo-controlled pivotal clinical trial of dipraglurant in PD-LID patients in the first quarter of 2020. The study will be conducted at multiple sites in the United States and will target enrolment of approximately 140 patients.
We have also received orphan drug designation from the US FDA for dipraglurant in PD-LID and expect to report top-line results in the third quarter of 2021