IRLAB reports Last Patient Last Visit (“LPLV”) achieved in Phase IIb clinical study of mesdopetam in PD-LIDs with top-line results anticipated mid-January 2023

“Last patient last visit is an important milestone as it confirms that we have now successfully completed the treatment period in this clinical study. Final data collection will now be performed, and the database will be locked. This is then followed by the pre-specified statistical analyses, and we expect to report top-line results in mid-January,” said Nicholas Waters, EVP and Head of R&D, IRLAB.

Mesdopetam, an oral dopamine D3 antagonist, is being developed in partnership with Ipsen as a treatment for Parkinson’s disease levodopa-induced dyskinesias (PD-LIDs), a severe form of troublesome involuntary movements commonly occurring in Parkinson’s disease. The Phase IIb study of mesdopetam is a randomized, double-blind, placebo-controlled study with the aim of evaluating the efficacy, safety and, optimal dose of mesdopetam in people with PD-LIDs. The study randomized 156 patients distributed across four groups, three dose levels of mesdopetam and a placebo group with approximately 40 patients in each group with a treatment period of three months. The study was conducted at 46 study sites in Europe, Israel and in the US.

“The final stages of this important trial, for what could be a major breakthrough in treating this severe unmet need in Parkinson’s disease are now underway. I would like to thank the dedicated team for their constant hard work and continued diligence to ensure we report this data as soon as possible,” said Richard Godfrey, Chief Executive Officer, IRLAB.

The global specialty pharma company Ipsen holds the exclusive right for further clinical development and commercialization of the mesdopetam program in PD-LIDs and potentially other indications.