IRLAB fails primary endpoint in PD-LIDs
Positive secondary endpoint keeps the door open
Conference call today at 10:00 CET
Mesdopetam fails in patient diaries but hits in UDysRS
Yesterday after market close, IRLAB announced the top-line results from its Ph 2b trial of mesdopetam in Parkinson's disease levodopa induced dyskinesia (PD-LIDs). IRLAB communicated that the primary endpoint, change in average daily hours of ON-time without troublesome dyskinesia as assessed with patient diaries, failed by not reaching statistical significancy compared to placebo after 12 weeks (no numbers provided). However, the company highlighted a potentially positive anti-dyskinetic effect on the secondary endpoint UDysRS (part 1, 3 and 4) (a scale measuring ON-phase dyskinesia), where the drug significantly reduced dyskinesia already from week 4 (p=0.045) (week 8, p=0.004; week 12 p=0.026) at the 7.5 mg bd dose. This effect seems to be supported by numerical improvements in scales measuring disability associated to dyskinesia (UDysRS part 1b and 4, we believe). Unexpectedly, the results show that mesdopetam numerically reduced OFF time in a dose-dependent manner compared to placebo. Finally, IRLAB reported that the MDS-UPDRS part 2 (motor aspects of daily living) was unchanged, suggesting that mesdopetam does not impair normal motor function. In terms of safety, the drug was well tolerated and had an acceptable safety profile. 7 randomised patients were reported to experience serious adverse events (SAEs) of which 4 were in the mesdopetam arm and 3 in the placebo arm (1 related to mesdopetam, details undisclosed).