IRLAB Therapeutics — EMA alignment on mesdopetam Phase III plans

IRLAB has bolstered the value of its lead programme, mesdopetam in levodopa-induced dyskinesias (PD-LIDs), following confirmation that the European Medicines Agency (EMA) is aligned with the company on its proposed plans for Phase III. The EMA has agreed on the primary endpoint for the Phase III programme being the Unified Dyskinesia Rating Scale (UDysRS), on which mesdopetam demonstrated a statistically significant improvement (p=0.026) in the prior Phase IIb trial (where it was a secondary endpoint). Importantly, IRLAB is now aligned with the US Food and Drug Administration (FDA) and the EMA and, hence, is in a position to proceed with preparations for the registrational studies of the candidate while meeting regulatory requirements in both the US and Europe. With this latest update, we anticipate partnering discussions to pick up pace in the coming weeks.