(IRLABA) IRLAB Therapeutics — Mesdopetam Phase IIb top-line data
Based in Sweden, IRLAB Therapeutics is focused on developing novel drugs for the treatment of neurodegenerative diseases utilising its ISP technology platform. Its two lead assets are in late-stage clinical trials for the symptomatic treatment of Parkinson’s disease (PD): mesdopetam (D3 antagonist) and pirepemat (PFC enhancer).
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 c 60% following the news, which likely reflects market uncertainty over mesdopetam’s future clinical development. Based on this news, our valuation and estimates are under review.
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