First European patients dosed in IRLAB’s Phase IIb/III mesdopetam study
IRLAB (Nasdaq Stockholm: IRLAB A) announced today that the first patients in Europe have been dosed in the clinical Phase IIb/III study with mesdopetam. Regulatory authorities across Europe have approved the study and Poland is the first European country where patients have been dosed with mesdopetam.
“The Phase IIb/III study is now running on two continents, in the US and Europe. It is great that European sites have now started recruiting and treating patients in this multinational study, maintaining a good recruitment pace. More countries will follow in the coming months,” says Nicholas Waters, CEO at IRLAB.
Mesdopetam is currently being evaluated in an international clinical Phase IIb/III study for the treatment of levodopa-induced dyskinesias in Parkinson’s disease, PD-LIDs. The ongoing study is a randomized, double-blind and placebo-controlled study with the aim of evaluating the effect of mesdopetam in patients with Parkinson’s disease affected by troublesome dyskinesias. The primary outcome measure is change in daily hours of ON-time without troublesome dyskinesia as assessed with 24-hour patient home diaries. The study is designed to randomize approximately 140 patients distributed across four groups, three groups with different dose levels of mesdopetam and one placebo group with approximately 35 patients in each group. Each patient will be treated for three months in the study. The strategy for the Phase IIb/III study has been developed in collaboration with regulatory and clinical experts based on the results from IRLAB’s successful Phase I, Phase Ib and Phase IIa studies with mesdopetam.
The Phase IIb/III study started patient recruitment in the US following FDA’s IND acceptance in November 2020. The first corresponding approval in Europe was obtained in February 2021. The parallel application processes to regulatory authorities and ethics committees in all selected European countries and Israel have been completed according to plan.