IRLAB completes recruitment in Phase IIb study of mesdopetam (IRL790) in patients with Parkinson’s levodopa-induced dyskinesias
Gothenburg, Sweden, September 12, 2022 – IRLAB (Nasdaq Stockholm: IRLAB A), a clinical-stage biopharmaceutical company discovering and developing novel treatments for the most troublesome symptoms of Parkinson’s disease, today announced that the last participating patient has been randomized and entered the ongoing Phase IIb study of lead candidate mesdopetam (IRL790). Mesdopetam, a dopamine D3 antagonist, is being developed in partnership with Ipsen as a treatment for Parkinson’s disease levodopa-induced dyskinesias (PD-LIDs) aiming to improve patient quality of life. Top-line results are expected around the end of the year.
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Gothenburg, Sweden, September 12, 2022 – IRLAB (Nasdaq Stockholm: IRLAB A), a clinical-stage biopharmaceutical company discovering and developing novel treatments for the most troublesome symptoms of Parkinson’s disease, today announced that the last participating patient has been randomized and entered the ongoing Phase IIb study of lead candidate mesdopetam (IRL790). Mesdopetam, a dopamine D3 antagonist, is being developed in partnership with Ipsen as a treatment for Parkinson’s disease levodopa-induced dyskinesias (PD-LIDs) aiming to improve patient quality of life. Top-line results are expected around the end of the year.
“Considering current conditions when mounting global complexities have affected so many clinical studies, it is a major achievement to complete recruitment for this important study. We have seen a high interest throughout the study, which speaks to the great unmet treatment need for people living with Parkinson’s and dyskinesia,” said Nicholas Waters, EVP and Head of R&D, IRLAB.
The Phase IIb study with mesdopetam is designed as a randomized, double-blind, placebo-controlled study with the aim of evaluating the effects of mesdopetam in patients with Parkinson’s disease affected by levodopa-induced dyskinesias (LIDs). The primary outcome measure is change in daily hours of ON-time without troublesome dyskinesia as assessed with 24-hour patient home diaries. The Phase IIb study is conducted at 46 sites across Europe, Israel and the US, and has now reached its recruitment goal.
“I’m grateful for the confidence and trust that the patients and their families have afforded us in participating in this trial; and for the ongoing diligent work of the clinical development teams as we progress towards the final stages of this trial. I look forward to reporting the top-line data around the end of the year,” said Richard Godfrey, CEO, IRLAB.
Further information will be provided once the final patient has completed the three-month treatment period. This will be followed by database lock and subsequent data analyses before top-line results are communicated around the end of the year. More information can be found on clinicaltrials.gov: NCT04435431 and EudraCT: 2020 -002010-41.
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