IRLAB Therapeutics: EoP2 FDA feedback sets the table for Ph 3 - ABG
This is a third party research report and does not necessarily reflect our views or values
FDA aligns with Ph 3 design presented at IRLAB's 2023 CMD
Design compatible with earlier Ph 2b, to complement future Ph 3 data
Need for cash infusion or partnership to start Ph 3
Mesdopetam EoP2 FDA feedback on the table
Today, IRLAB shared the meeting minutes from the mesdopetam end-of-Ph 2 (EOP2) meeting with the FDA held on 20 February. As a reminder, IRLAB submitted a comprehensive data package including all data generated so far with mesdopetam (Ph 1b, Ph 2a, Ph2b) to the FDA in Dec'23. Importantly, the FDA aligned with the proposed programme on the details regarding patient population, treatment duration, primary and secondary endpoint(s), study size and safety monitoring. PD patients eligible for the trial must be on stable levodopa dosing, as in previous mesdopetam studies and in total 200-250 patients will be randomized 1:1 to 7.5 mg bid mesdopetam or placebo control. The treatment will be administered for 12 weeks, after which the primary endpoint UDysRS parts 1, 3, 4 vs. baseline will be read out. Secondary endpoints include subsections of MDS-UPDRS and 24-hr motor diaries. >100 patients need to be treated with mesdopetam for one year in a safety extension of the trial.
Design compatible with earlier Ph 2b, to complement future Ph 3 data
Need for cash infusion or partnership to start Ph 3
Mesdopetam EoP2 FDA feedback on the table
Today, IRLAB shared the meeting minutes from the mesdopetam end-of-Ph 2 (EOP2) meeting with the FDA held on 20 February. As a reminder, IRLAB submitted a comprehensive data package including all data generated so far with mesdopetam (Ph 1b, Ph 2a, Ph2b) to the FDA in Dec'23. Importantly, the FDA aligned with the proposed programme on the details regarding patient population, treatment duration, primary and secondary endpoint(s), study size and safety monitoring. PD patients eligible for the trial must be on stable levodopa dosing, as in previous mesdopetam studies and in total 200-250 patients will be randomized 1:1 to 7.5 mg bid mesdopetam or placebo control. The treatment will be administered for 12 weeks, after which the primary endpoint UDysRS parts 1, 3, 4 vs. baseline will be read out. Secondary endpoints include subsections of MDS-UPDRS and 24-hr motor diaries. >100 patients need to be treated with mesdopetam for one year in a safety extension of the trial.