Addex Therapeutics, a leading company pioneering allosteric modulation-based drug discovery and development, announced that the US Food and Drug Administration (FDA) has granted orphan drug designation to dipraglurant for the treatment of levodopa-induced dyskinesia associated with Parkinson’s disease (PD-LID). Orphan drug status provides Addex with a number of benefits including reduced development costs and seven years US market exclusivity from launch. Dipraglurant is a novel small molecule inhibitor of the metabotropic glutamate receptor 5 (mGluR5) that has successfully completed Phase II proof-of-concept testing in Parkinson's disease (PD) patients suffering from debilitating levodopa-induced dyskinesia (LID), an indication that has no approved treatment options. Addex is currently conducting an mGlu5 receptor occupancy clinical trial and is preparing to start a Phase III pivotal trial in PD-LID.
“Orphan drug status for dipraglurant in PD-LID is an important regulatory milestone for us and recognizes the therapeutic benefits that dipraglurant can bring to PD patients“, said Sonia Poli, CSO of Addex. “Dipraglurant has already demonstrated its potential to reduce dyskinesia in PD patients and we have started consultation with the FDA to define the clinical development program in this rare disease.”
“Achieving orphan drug designation is a key milestone as we execute our strategy of focusing Addex portfolio of clinical programs in rare neurological disorders”, said Tim Dyer, CEO of Addex. “We recently reported positive interim data from our ongoing mGluR5 receptor occupancy clinical trial and now plan to move dipraglurant directly into a Phase III pivotal trial in the US.”
