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 levodopa-induced dyskinesia associated with Parkinson’s disease (PD-LID). This is a disease with significant commercial opportunity as improved therapies are needed.
We believe that, subject to regulatory approval, dipraglurant may offer an innovative and differentiated treatment approach from existing therapies.
In a 28 day Phase 2a placebo-controlled clinical trial, conducted in the United States and Europe, in patients with PD-LID, dipraglurant met its primary end point, was generally well tolerated and no clinically significant abnormalities of safety monitoring parameters occurred. In addition, at Day 1 and Day 14, dipraglurant showed statistically significant effects on PD-LID clinical symptoms, as measured using the modified abnormal involuntary movement scale, or mAIMs. However, an increasing placebo response resulted in the effect of dipraglurant on PD-LID clinical symptoms not showing statistical significance at Day 28. You can learn more about the Phase 2a clinical results in our Corporate Presentation.
We are planning to initiate a placebo-controlled Phase 2b/3 pivotal clinical trial of dipraglurant in PD-LID patients in the first half of 2021, pending removal of governmental restrictions and lessening of the impact of the global coronavirus pandemic on the U.S. healthcare system, which delayed our previously anticipated initiation in the first quarter of 2020.
The study is expected to be conducted at approximately 50 sites in the United States and target enrollment of approximately 140 patients. We have received orphan drug designation from the United States Food and Drug Administration, or FDA, for dipraglurant in PD-LID and expect to report topline results in the second quarter of 2022.