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 rehabilitation.
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.
We have received orphan drug designation from the FDA, for dipraglurant in PD-LID.