IRLAB Therapeutics - Q4 report: mesdopetam on track - ABG

Mesdopetam EOP2 FDA meeting on 20 Feb, feedback 30 days later
Pirepemat Ph 2b full enrolment in Q3'24e
Webcast today at 10:00 CET


Mesdopetam EOP2 soon, pirepemat full recruitment in Q3e

During the quarter, IRLAB's main focus has been the preparation and submission of mesdopetam's end-of-Ph 2 meeting with the FDA, in which the Ph 3 design will be defined. The meeting is scheduled for 20 February, with feedback expected 30 days after it. In December, the IRL757 programme for the treatment of apathy received a grant from the Michael J. Fox Foundation worth over USD 2m and at the same time the project was announced to be Ph 1 ready, with expected start in H1'24e. Yesterday an update was provided on pirepemat's Ph 2b study React-PD communicating that patient baseline falls frequency in the study was higher than anticipated, giving a higher likelihood to observe a treatment effect (see our note). Full patient enrolment is expected in Q3'24e, followed by a one-month baseline period, 3 months treatment period and data curation. Thus, we believe the topline readout could be expected by YE'24e/Q1'25e. On a separate note, IRLAB hosted a Capital Markets Day in Stockholm on 17 Oct focusing on the mesdopetam programme and future strategy (see our previous note).

Länk till analysen i sin helhet: https://cr.abgsc.com/foretag/irlab-therapeutics/Equity-research/2024/2/irlab-therapeutics---q4-report-mesdopetam-on-track/