Mesdopetam phase IIb top-line data as a treatment for Parkinson’s disease levodopa-induced dyskinesias
IRLAB Therapeutics has announced top-line data from its Phase IIb trial investigating mesdopetam as a treatment for Parkinson’s disease levodopa-induced dyskinesias (PD-LIDs)
The drug did not meet the primary outcome of the study, change in daily hours of ‘ON time’ (the length of time a patient does not have symptoms) without troublesome dyskinesia compared to placebo with statistical significance . However, the results confirmed the safety and tolerability of mesdopetam and met the secondary efficacy endpoint in demonstrating significant anti-dyskinetic effects as measured by the Unified Dyskinesia Rating Scale (UDysRS), a clinically recognised scale for measuring dyskinesias.
We believe the importance of the secondary endpoint should not be overlooked; FDA approval of Gocovri in PD-LID was based on two pivotal studies assessing changes in the UDysRS as the primary outcome, demonstrating its clinical relevance.
IRLAB’s stock dropped 60% following the news, which likely reflects market uncertainty over mesdopetam’s future clinical development.
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