IRLAB's Mesdopetam Advances: Positive Feedback from EMA Confirms Alignment with FDA on Phase III Program

IRLAB Therapeutics AB (Nasdaq Stockholm: IRLAB A), a company focused on discovering and developing novel treatments for Parkinson's disease, has received positive feedback from the European Medicines Agency (EMA) regarding its Phase III program for mesdopetam. This confirmation aligns with the previously received feedback from the US Food and Drug Administration (FDA), indicating a harmonized approach to the development of the drug candidate.

The EMA's positive feedback is a significant milestone for IRLAB, as it confirms the company's proposed design for the Phase III program. Both regulatory authorities have provided clear guidance and agreed on key components of the program, ensuring that the development plan meets the requirements of both the US and European markets. This alignment can help streamline the development process and potentially reduce the time and resources required to complete the Phase III program.

The key components of the Phase III program, as outlined by both the FDA and the EMA, align with IRLAB's original plans for mesdopetam's development. The patient population will be in alignment with previous clinical studies in the mesdopetam program, focusing on people living with Parkinson's disease and levodopa-induced dyskinesias (PD-LIDs). The primary endpoint will be UDysRS part 1+3+4, a validated scale for assessing dyskinesia in PD-LIDs. Secondary endpoints will be based on subsections of UDysRS and MDS-UPDRS, as well as 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, and 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.



The regulatory alignment between the FDA and EMA has several implications for the timelines and resources required for the Phase III program. Firstly, a smoother development process with fewer delays can help reduce the overall costs associated with the program. This can positively impact IRLAB's financial projections by reducing the expenses related to the development of mesdopetam. Secondly, the alignment can also help build confidence among potential partners and investors, as it demonstrates that the company is on track to meet regulatory requirements and bring the drug to market. This can potentially lead to increased interest in the company and its drug candidate, which could positively impact the company's financial projections.

In conclusion, the positive feedback from the EMA confirms the alignment with the FDA on the Phase III program for mesdopetam, providing a strong foundation for the further development of the drug candidate. This regulatory alignment can help streamline the development process, reduce costs, and build confidence among potential partners and investors. As IRLAB continues to advance mesdopetam through the Phase III program, the company remains well-positioned to bring this promising treatment to market and potentially improve the lives of people living with Parkinson's disease and levodopa-induced dyskinesias.