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IRLAB Therapeutics reported positive feedback from its FDA end-of-Phase II (EoP2) meeting earlier in the week for mesdopetam. According to management, the meeting was held in a constructive and engaging spirit, and discussions during the meeting suggested alignment between the company and the regulatory authority on the design of a Phase III programme for mesdopetam as a potential treatment for levodopa-induced dyskinesias (PD-LIDs). In our view, this update is a positive sign for further clinical development of IRLAB’s lead asset, and we expect management to share more details on the formal feedback, which is expected in approximately 30 days.
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