Report

IRLAB Therapeutics - Collaboration to support FDA Ph III progression

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.
Underlying
IRLAB Therapeutics

IRLAB Therapeutics AB is a Sweden-based research and development company. It focuses on illnesses in the central nervous system and primarily on development of drugs to assist patients with Parkinson's disease. The Company possesses a research platform Integrative Screening Process (ISP), which aims to discover and develop drug candidates for the treatment of brain diseases. The Company operates projects on both clinical phase and preclinical phases. The primary projects are IRL790 and IRL752, both on clinical phase. The IRL790 project is a psychomotor stabilizer for the treatment of levodopa (L-dopa) amino acid that dyskinesia induces in Parkinson's Disease (PD-LIDs) and Parkinson Disease psychosis (PD-Psychosis). The IRL752 project aims at cortical enhancement for the treatment of Parkinson Disease Dementia (PD-D) and Behavioral and Psychological Symptoms of Dementia (BPSD).

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Edison Investment Research
Edison Investment Research

Edison is an investment research and advisory company, with offices in North America, Europe, the Middle East and AsiaPac. The heart of Edison is our world renowned equity research platform and deep multi-sector expertise. At Edison Investment Research, our research is widely read by international investors, advisors and stakeholders. Edison Advisors leverages our core research platform to provide differentiated services including investor relations and strategic consulting.

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Analysts
Sean Conroy

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