GOTHENBURG, SWEDEN / ACCESSWIRE / September 6, 2022 / IRLAB Therapeutics (STO:IRLAB-A)(FRA:6IRA) Gothenburg, Sweden, September 6, 2022 - IRLAB Therapeutics AB (Nasdaq Stockholm: IRLAB A), a clinical-stage biopharmaceutical company discovering and developing novel treatments for the most troublesome symptoms of Parkinson's disease, today 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 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 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.

"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.

IRLAB remains responsible for the completion of the ongoing Phase IIb study with mesdopetam, more information can be found on clinicaltrials.gov: NCT04435431 and EudraCT: 2020 -002010-41. Ipsen is making preparations to assume responsibility for the mesdopetam clinical development program through registration and commercialization.

For more information:

Richard Godfrey, CEO
Phone: +46 730 70 69 00
E-mail: richard.godfrey@irlab.se

Nicholas Waters, EVP and Head of R&D
Phone: +46 730 75 77 01
E-mail: nicholas.waters@irlab.se

About mesdopetam

Mesdopetam (IRL790) 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 and thereby increases daily ‘good ON-time' in patients with Parkinson's. Preclinical studies show that mesdopetam is a potent and efficacious antidyskinetic, and that mesdopetam also has the potential to prevent the development of dyskinesia. In 2021, Ipsen, a specialty pharma company, acquired exclusive global rights to the development and commercialization of mesdopetam.