IRLAB updates on portfolio development milestones

February 13, 2023

Gothenburg, Sweden, February 13, 2023 – IRLAB Therapeutics AB (Nasdaq Stockholm: IRLAB A), a company discovering and developing novel treatments for Parkinson’s disease, today announced that the company has assessed the operational priorities for 2023 resulting in an update to the portfolio development milestones. This will not impact the priority of the ongoing Phase IIb study of pirepemat in PD-Falls. The preclinical programs will proceed according to their respective plans; IRL757 will proceed to be Phase I ready by year-end 2023, IRL942 will be Phase I ready in H1 2024 and P003 candidate IRL1117 is just initiating its preclinical program with in-house R&D activities during 2023. The analysis of the completed Phase IIb study of mesdopetam continues, and it is anticipated that further data will be presented during H1 2023.

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Gothenburg, Sweden, February 13, 2023 – IRLAB Therapeutics AB (Nasdaq Stockholm: IRLAB A), a company discovering and developing novel treatments for Parkinson’s disease, today announced that the company has assessed the operational priorities for 2023 resulting in an update to the portfolio development milestones. This will not impact the priority of the ongoing Phase IIb study of pirepemat in PD-Falls. The preclinical programs will proceed according to their respective plans; IRL757 will proceed to be Phase I ready by year-end 2023, IRL942 will be Phase I ready in H1 2024 and P003 candidate IRL1117 is just initiating its preclinical program with in-house R&D activities during 2023. The analysis of the completed Phase IIb study of mesdopetam continues, and it is anticipated that further data will be presented during H1 2023.

The ongoing Phase IIb study of pirepemat, evaluating the dose-response effect in people with Parkinson’s with frequent falls (PD-Falls), is active and progressing to plan with 28 of 39 planned sites in five European countries. Patient recruitment is slower than anticipated, and actions are ongoing to address this. The updated estimates predict the study will be fully recruited by the year-end 2023 with top-line results in H1 2024. Activities are continuously ongoing to support patient screening and recruitment for timely completion of the study.

The company’s three preclinical programs; IRL757, IRL942, and IRL1117 will proceed according to their respective preclinical development, toxicology and GMP manufacturing plans. IRL757, in development for apathy in neurological disorders, is expected to be Phase I ready year-end 2023. IRL942, in development for cognitive decline in neurological disorders, is expected to be Phase I ready during H1 2024. Drug candidate IRL1117 from the P003 project continues with in-house R&D activities in preparation for Phase I enabling toxicology studies and manufacturing activities in 2024.

The analysis of the completed mesdopetam Phase IIb study is continuing, and further data is expected to be presented at a scientific congress during H1 2023.

More information about the respective clinical and preclinical programs will be provided as the development programs progress.

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