IRLAB Therapeutics

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 program 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.
• The estimated total sample size for Phase III will be 200-250 patients (1:1 active or control) with a treatment duration of 3 months.
• The dose to be evaluated in the Phase III program will be 7.5 mg twice daily.
• The required safety documentation will include a population of at least 100 patients treated with a clinically relevant dose of mesdopetam during 1 year in the safety extension of the phase III program.

Importantly, efficacy on the planned primary endpoint in the Phase III program, UDysRS part 1+3+4, was prespecified 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).

“Following the successful End-of-Phase 2 meeting for mesdopetam, we are now delighted to conclude that the FDA’s formal meeting minutes confirm our plans for Phase III and validate the quality of our development activities. It is gratifying to see that the extensive work carried out by Irlab’s experienced team meets the requirements of the regulatory authority to move mesdopetam into a confirmatory clinical Phase III program," said Gunnar Olsson, CEO, IRLAB. 

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.