Events during the quarter
No material updates were provided in the report. During the quarter, IRLAB signed a strategic R&D agreement with Otsuka's McQuade Centre for Strategic Research and Development, LCC (MSRD), where MSRD will perform a preclinical evaluation of IRL757 and IRL942. After the reported period, IRLAB communicated that the data and safety monitoring board (DSMB) evaluated the safety and integrity of the Ph 2b study of pirepemat on PD-Falls concluding that the study was clear to continue without modifications. Since the end of May, the study has all the 38 clinical sites active across Europe. The company mentioned in the report that recruitment is going slower than anticipated, and actions are being taken in order to complete recruitment by YE'23e and provide top-line data as previously guided (H1'24e). Regarding mesdopetam, IRLAB communicated that they have parted ways with IPSEN, acquiring the rights of the molecule back. IRLAB agreed with Ipsen to pay a low-single-digit royalty based on future product sales. Together with this news, IRLAB presented a deeper analysis of the Ph 2b data showing a clearer picture of the effects of mesdopetam in PD-LIDs. The results were further expanded at a poster presented at the MDS congress on 28 Aug (link). With the data in hand, IRLAB sees the current data package as the foundation for continuing the development of mesdopetam into Ph 3 trials. The company is currently compiling the necessary documentation for an end-of-Phase 2 meeting with the FDA to define the Ph 3 programme.
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