IRLAB starts Phase IIb/III study with mesdopetam in the US
IRLAB (Nasdaq Stockholm: IRLAB A) announced today that recruitment in the phase IIb/III study with mesdopetam (IRL790) has started in the US. Mesdopetam is in development for the treatment of levodopa-induced dyskinesias in Parkinson’s disease, PD-LIDs, with the objective to increase daily “good ON-time”.
“Patient recruitment started four weeks after FDA acceptance of the IND for mesdopetam, which is a testament of the team’s diligent work. Mesdopetam can make a big difference for Parkinson's disease patients. We now take additional important steps towards our goal to offer efficient treatment,“ says Nicholas Waters, CEO at IRLAB.
The clinical phase IIb/III study with mesdopetam 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 dose levels of mesdopetam and a placebo group with approximately 35 patients in each group. Each patient will have a three-month treatment period.
Parallel application processes for the Phase IIb/III study to regulatory authorities and ethics committees are ongoing in selected European countries.