IRLAB Therapeutics have announced that its partner Ipsen has initiated clinical studies with drug candidate mesdopetam in accordance with its development plan.
These are standard clinical pharmacokinetic studies that will run in parallel to the Phase IIb study with mesdopetam that is currently being conducted by IRLAB with results anticipated around the end of the year 2022.
“We are encouraged by Ipsen’s enthusiasm and commitment to the development plan for mesdopetam. This timely execution of the clinical pharmacokinetic studies in parallel with our Phase IIb study will ensure efficient continuation of the late-stage development program for mesdopetam,” says Richard Godfrey, CEO at IRLAB.
“These clinical pharmacokinetics studies will provide a standard set of data typically required for late-stage drug development and in readiness for potential further studies with mesdopetam.”
In 2021, Ipsen, a specialty pharma company, acquired exclusive global rights to the development and commercialization of the mesdopetam program. Ipsen plan to initiate three clinical pharmacology studies in healthy volunteers including a pharmacokinetic, a drug-to-drug interaction, and a mass balance study. These clinical pharmacokinetics studies will provide a standard set of data typically required for late-stage drug development and in readiness for potential further studies with mesdopetam. These three studies are expected to be completed between Q3 2022 and Q1 2023.
IRLAB remains responsible for the completion of the ongoing Phase IIb study with mesdopetam. Ipsen is making preparations to assume responsibility for the mesdopetam clinical development program through registration and commercialization.
Photo of Richard Godfrey. Nils Olav Mevatne/BerGenBio