Pirepemat full recruitment slight delay, but readout still in time
During the quarter, IRLAB announced the reacquisition of mesdopetam's rights from Ipsen, giving them back full control of the clinical development of the drug candidate. Now, IRLAB is focused in the preparation of the end-of-phase-2 (EOP2) meeting with the FDA. For this, IRLAB initiated in October a collaboration with US regulatory advisors Clintrex and ProPharma Group. We expect the EOP2 meeting to take place in H1'24. Regarding pirepemat, the data safety monitoring board (DSMB) of the ongoing Ph 2b study unanimously recommended the continuation of the study after review of the first completed 25 patients. During the fall, the pirepemat study recruited slower than expected, and now IRLAB expects full recruitment in Q1'24e (YE'23). However, top-line readout is still expected within previous guidance, in Q2'24e (H1'24 previous guidance). Last week, IRLAB held its Capital Markets Day (CMD), where the company provided insights of the regulatory path with the FDA towards mesdopetam's Ph 3 programme (link). Discussions with MSRD around a potential collaboration for the preclinical assets IRL757 and IRL942 are ongoing as previously communicated. Regarding IRL757, IRLAB expects to have everything ready to file for a Ph 1 study by YE'23e. Timelines for IRL942 are unchanged, with the asset expected to be Ph 1 ready in '24.
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