IRLAB communicated today that the Data and Safety Monitoring Board (DSMB) has evaluated the safety and integrity (efficacy was not evaluated) of the pirepemat Ph 2b study on falls frequency in patients with Parkinson's Disease (PD-falls), and concluded that the study can continue without modifications. The evaluation of pirepemat was done on the initial 25 patients participating and completing the study. The DSMB is an independent committee of experts responsible for reviewing clinical trial data on an ongoing basis during ongoing studies to ensure safety and integrity of the data in order to provide recommendations (continuation/ modification/termination).
Timelines maintained; pirepemat top-line data in H1'24e
The pirepemat Ph 2b study has all 38 clinical sites active across several European countries. IRLAB expects patient recruitment and randomisation to be completed by YE'23, followed by the 3-month treatment period (plus follow-up visits, data management and database lock). Top-line results are expected in H1'24. Regarding mesdopetam, IRLAB will present data from the Ph 2b study at the MDS Congress on 27-31 May
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