IRLAB Therapeutics AB, a clinical-stage biopharmaceutical company discovering and developing novel treatments for the most troublesome symptoms of Parkinson’s disease, says 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 top-line results anticipated around the end of the year 2022.
In 2021, Ipsen, a specialty pharma company, acquired exclusive global rights to the development and commercialization of the mesdopetam program. Ipsen plans 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.
“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,” said Richard Godfrey, CEO at IRLAB Therapeutics.
IRLAB Therapeutics 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.
Mesdopetam is a dopamine D3-receptor antagonist being developed for the treatment of levodopa-induced dyskinesias (LIDs), a severe form of troublesome involuntary movements commonly occurring in Parkinson’s disease.
Mesdopetam also has potential in treating Parkinson’s disease psychosis (PD-P). In clinical studies, mesdopetam reduces time spent with troublesome dyskinesia. Preclinical studies show mesdopetam is a potent and efficacious antidyskinetic, and that it also has the potential to prevent the development of dyskinesia.
IRLAB discovers and develops novel treatments of Parkinson’s disease and other CNS disorders. The company’s most advanced drug candidates, mesdopetam and pirepemat, are in phase IIb and are designed to treat some of the most difficult symptoms related to Parkinson’s disease. In 2021, IRLAB entered an exclusive global license agreement with Ipsen for the development and commercialization of mesdopetam.
IRLAB has generated all its drug candidates and continues to discover innovative drug candidates for the treatment of CNS disorders through its systems biology based integrative screening process (ISP) research platform. In addition to IRLAB’s clinical pipeline, the company is also progressing two preclinical programs, IRL942 and IRL757, towards phase I studies.