IRLAB Therapeutics AB announced the receipt of written minutes from a recent End-of-Phase 2 meeting for mesdopetam with the US Food and Drug Administration, FDA. The minutes confirm the previously communicated positive verbal feedback from the meeting. Based on this successful outcome, IRLAB will now move forward with the preparations of the Phase III program.

At the End-of- Phase 2 meeting with the FDA, aspects related to all parts of the development plan for mesdopetam, including the design of a Phase III program, were evaluated and commented upon, based on the briefing package submitted to the agency before the meeting. The written minutes, which confirm the verbal positive feedback provided at the meeting, are positive for the mesdopetam program and its advancement into Phase III. The minutes cover the FDA's opinion on the robustness of four key areas of the mesdopetam programs to date: i) preclinical data, ii) toxicology,iii) clinical pharmacology (Phase Ia), and iv) clinical studies (Phase Ib, IIa and IIb).

Thus, the response from the agency means that the data generated in all key areas is sufficient and adequate to move the program ahead into Phase III. Alignment with the FDA was confirmed regarding the Phase III program including the following key components: The patient population will be in alignment with previous clinical studies in the mesdopetam Program. The primary endpoint will be UDysRS part 1+3+4. The secondary endpoints will be based on subsections of UDysRS and MDS-UPDRS, and 24-hour Motor diaries.

Importantly, efficacy on the planned primary endpoint in the Phase III program, UDysRS part 1+ 3+4, waspecified and evaluated in the Phase IIb study of mesdopetam. Using this specific assessment scale for dyskinesia, the Phase IIb study demonstrated a nominally significant and clinically meaningful anti-dyskinetic effect of mesdopetam at 7.5 mg twice daily as compared to placebo (ITT analysis, p=0.026). Based on the positive feedback from the FDA, IRLAB continues the preparations for the Phase III program and will now engage with European regulatory agencies in accordance with standard practice before initiation of the Phase III program.