IRLAB Provides Update on Mesdopetam's Phase IIb Study Data and the Plans Toward Phase III

GOTHENBURG, SE / ACCESSWIRE / August 21, 2023 / IRLAB Therapeutics (STO:IRLAB-A)(FRA:6IRA), a company discovering and developing novel treatments for Parkinson's disease, today announced further information on the results from mesdopetam's clinical Phase IIb study in Parkinson's disease levodopa-induced dyskinesias (PD-LIDs) and Phase III preparatory Phase I studies performed by Ipsen. The results indicate that mesdopetam has dose-dependent anti-dyskinetic and anti-parkinsonian effects combined with a tolerability and safety profile not different from placebo, giving mesdopetam a unique position in the competitive landscape. The comprehensive data package developed by IRLAB and Ipsen provides a solid foundation for continuing the development of mesdopetam to Phase III. IRLAB now proceeds with preparations for Phase III, requesting an end-of-Phase 2 meeting with the US FDA to define the Phase III study program. A webcast in conjunction with the announcement will be held on August 22, 2023, at 10:00 CEST, access details below.

In-depth analyses of the Phase IIb study data have now been completed confirming the great potential of mesdopetam in people living with PD-LIDs. The objectives of the study were to investigate the efficacy and safety of three doses of mesdopetam (2.5, 5, and 7.5 mg twice daily (b.i.d.)), as compared to placebo, in people living with PD-LIDs to guide dose selection for Phase III. Top-line results from the Phase IIb study of mesdopetam in PD-LIDs were communicated in January 2023.

In the in-depth evaluation of the Phase IIb study data the effects in subjects based both on their randomized dose (FAS population) and based on the actual dose received in subjects compliant with the protocol (PS population), were analyzed. Since dose adjustment was allowed at one time during this study, analyses based on the actual dose received are important to get a full understanding of the dose dependency and the treatment effects. These analyses provide the basis for dose selection for Phase III.

"We are pleased to see clear and clinically meaningful anti-dyskinetic effects of mesdopetam in the analyses of the Phase IIb study data. Consistent dose-response patterns were observed across the key efficacy endpoints assessing dyskinesia: "good ON"-time, UDysRS, UDysRS subscales. This, in combination with unchanged MDS-UPDRS part 2 scores demonstrates that mesdopetam shows anti-dyskinetic efficacy without affecting normal motor function, or negatively impacting the anti-parkinsonian treatment effect of levodopa. The reduced OFF-time even indicates that mesdopetam has anti-parkinsonian effects," said Nicholas Waters, EVP and Head of R&D, IRLAB. "The dose-dependent effects make it possible to select dose for Phase III."