IRLAB Therapeutics

All technical aspects in the preparation of mesdopetam for Phase III were completed during the IRLAB/Ipsen collaboration. These include all data generated in preclinical studies, all necessary Phase I, Phase Ib, Phase IIa and IIb studies, an expanded IPR portfolio, and CMC development including production of study drug for Phase III. Recently, Ipsen successfully completed three Phase I studies: a pharmacokinetic, a drug-to-drug interaction, and a mass balance study.

“We and our independent advisors have a strong belief in the clinical utility and commercial potential of mesdopetam and we are committed to pursuing the development of mesdopetam through Phase III for patient benefit and commercial success. The full analysis of the mesdopetam Phase IIb study demonstrates that mesdopetam has great potential as a first-in-class efficacious and well-tolerated anti-dyskinetic treatment for people with PD-LIDs,” said Gunnar Olsson, CEO, IRLAB.

“The collaboration with Ipsen has been highly professional and productive. During the collaboration, Ipsen has conducted a number of important DMPK and safety studies and developed drug product to complete the Phase III preparations. We are working closely with Ipsen in the transfer of the project with the aim of securing the best possible prospects for mesdopetam to continue through Phase III and to ensure that mesdopetam can be made available to the benefit of people living with Parkinson’s,” said Nicholas Waters, EVP and Head of R&D, IRLAB.

IRLAB will pursue the regulatory path towards Phase III and will approach the FDA for an end-of-Phase 2 meeting to define the design of a Phase III program. Ipsen is supporting IRLAB with the preparation for such end-of-Phase 2 meeting.