Dipraglurant is a novel orally available highly selective metabotropic glutamate receptor subtype 5 negative allosteric modulator (mGlu5 NAM) which has completed Phase 1 and demonstrated efficacy in a Phase 2a proof of concept study 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.
Following termination of development in a pivotal Phase 2B/3 levodopa-induced dyskinesia associated with Parkinson's disease (PD-LID) study due to slow recruitment of patients and the consequential excessive costs of continuing development (announced June 17, 2022), we have initiated discussions with potential strategic partners to reinitiate Phase 2 development of dipraglurant in PD-LID or an alternative indication, including pain, substance use disorders (SUD), neurodevelopmental disorders and stroke.
We believe that, subject to regulatory approval, dipraglurant may offer an innovative and differentiated treatment approach from existing therapies in a number of disease areas where there is a significant need for improved treatment options.
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.
We have received orphan drug designation from the FDA, for dipraglurant in PD-LID.