IRLAB Receives End-of-Ph 2 Meeting Confirming Alignment with the FDA
GOTHENBURG, SE / ACCESSWIRE / August 21, 2023 / IRLAB Therapeutics (STO:IRLAB-A)(FRA:6IRA), a company discovering and developing novel treatments for Parkinson's disease, today announced further information on the results from mesdopetam's clinical Phase IIb study in Parkinson's disease levodopa-induced dyskinesias (PD-LIDs) and Phase III preparatory Phase I studies performed by Ipsen. The results indicate that mesdopetam has dose-dependent anti-dyskinetic and anti-parkinsonian effects combined with a tolerability and safety profile not different from placebo, giving mesdopetam a unique position in the competitive landscape. The comprehensive data package developed by IRLAB and Ipsen provides a solid foundation for continuing the development of mesdopetam to Phase III. IRLAB now proceeds with preparations for Phase III, requesting an end-of-Phase 2 meeting with the US FDA to define the Phase III study program. A webcast in conjunction with the announcement will be held on August 22, 2023, at 10:00 CEST, access details below.
IRLAB reports Last Patient Last Visit (“LPLV”) Achieved in Phase IIb Clinical Study of Mesdopetam in PD-LIDs with Top-Line Results Anticipated Mid-January 2023
GOTHENBURG, SWEDEN / ACCESSWIRE / September 12, 2022 / IRLAB Therapeutics (STO:IRLAB-A)(FRA:6IRA) IRLAB (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 the last participating patient has been randomized and entered the ongoing Phase IIb study of lead candidate mesdopetam (IRL790). Mesdopetam, a dopamine D3 antagonist, is being developed in partnership with Ipsen as a treatment for Parkinson's disease levodopa-induced dyskinesias (PD-LIDs) aiming to improve patient quality of life. Top-line results are expected around the end of the year.
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.