“The end-of-Phase 2 meeting is an important milestone for the mesdopetam program. The further development activities, including the design of the Phase III program, will be discussed at the meeting and, thus, the path to a future New Drug Application (NDA) should be outlined. The outcome of the meeting is also important in IRLAB’s business development activities for mesdopetam,” said Gunnar Olsson, CEO, IRLAB.

IRLAB is working together with the US advisory groups Clintrex, a clinical and regulatory strategy advisor and ProPharma Group (PPG), IRLAB’s regulatory agent in the US, to develop the strategy for the mesdopetam Phase III program. IRLAB, PPG, and Clintrex have prepared the Briefing Book, which describes the full mesdopetam clinical and non-clinical development program and the scope and design of the planned randomized, placebo-controlled Phase III program.

The purpose of an end-of-Phase 2 meeting is to ensure alignment with the US FDA prior to the start of Phase III. As part of the end-of-Phase 2 meeting, the US FDA evaluates the Phase III plans and study protocols combined with the data generated in previously completed studies, i.e. review of the safety profile and assessment of the effectiveness of the drug candidate. The US FDA may, in addition, notify if any additional information is necessary to support a future New Drug Application (NDA).

Information on the outcome of the meeting will be shared when IRLAB has received feedback from the US FDA, which could be up to 30 days after the meeting.