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
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
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.
Contact:
Tel: +46 70 576 14 02
Email: gunnar.olsson@irlab.se
Tel: +46 730 75 77 01
Email: nicholas.waters@irlab.se
About mesdopetam
The investigational drug mesdopetam (IRL790), a dopamine D3 receptor antagonist, is being developed as a treatment for Parkinson's disease levodopa-induced dyskinesias (PD-LIDs). The objective is to improve the quality of life for people living with Parkinson's and having a severe form of involuntary movements commonly occurring after chronic levodopa treatment. Around 25-40 percent of all people being treated for Parkinson's develop LIDs, which equates to approximately 1.4-2.3 million people in the eight major markets globally (
About IRLAB
IRLAB is discovering and developing a portfolio of transformative therapies targeting all stages of Parkinson's disease. The company has its origin in Nobel Laureate Prof.
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