IRLAB Therapeutics: Collaboration to support FDA Ph III progression - Edison

IRLAB is collaborating with two US-based advisory groups, Clintrex (clinical research company) and ProPharma Group (research consulting organisation) for expert guidance in preparing a brief package for mesdopetam to request an end-of-Phase II meeting with the US FDA. This development comes after the detailed analysis of Phase IIb trial data in August 2023, which confirmed the safety and tolerability of mesdopetam and indicated dose-dependent anti-dyskinetic and anti-Parkinsonian effects. We await the FDA’s approval for the progression of mesdopetam’s clinical development to a Phase III trial. Though mesdopetam’s development is the priority for IRLAB, the next key catalysts revolve around the anticipated top-line results for the Phase IIb pirepemat trial (H124) and the potential advancement of preclinical assets to Phase I ready stage during Q423–FY24.

Länk till analysen i sin helhet: https://www.edisoninvestmentresearch.com/research/company/irlab-therapeutics

Länk till analysen i sin helhet: https://www.edisoninvestmentresearch.com/research/report/irlab-therapeutics244374/preview