IRLAB Therapeutics AB announced the transfer of rights for the now Phase III-ready mesdopetam project to IRLAB. IRLAB now has secured full ownership of the mesdopetam project including, inter alia, all technology, rights, know-how, intellectual properties, and materials, and will control the further clinical development and future commercialization. As compensation, IRLAB will pay Ipsen a low single-digit royalty based on future product sales.

IRLAB and its advisors, with Ipsen's support, are now preparing for an end-of-Phase 2 meeting with the FDA as part of the detailed planning for Phase III. 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. 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.