Integrative Research Laboratories Sweden AB
Phase I program with IRL790 for treatment of dyskinesias and psychosis in Parkinson´s disease
Swedish Research Council
Parkinson's disease & PD-related disorders
IRL790 is a novel development candidate for the treatment of L-dopa induced dyskinesias (PD-LIDs) and psychosis in Parkinson´s disease (PD). IRL790 has been nominated based on highly promising preclinical results. IRL790, a psychomotor stabilizer, displays both attenuation of motor disabilities in preclinical models of PD-LID, and antipsychotic effects. This reflects its unique ability to normalize functional connectivity in the cortico-striatal pathways in the brain, known to be a central part of the pathophysiology in PD. From a competition perspective, IRL790 has a unique mechanism of action and is the only compound in development for treatment of both LID and psychosis in PD and will meet a large and increasing medical need. IRL790 has successfully past safety pharmacology and toxicology studies and an application for first-in-human clinical trials has been sent to Läkemedelsverket. IRL AB is now seeking financial support for the next step in the development of IRL790, a Phase I clinical program in healthy volunteers. The program consists of two parts. One single ascending dose study and one multiple dosing study. In addition, bioanalytical methods will be developed and used for pharmacokinetic evaluation of plasma samples from the subjects in the studies and a screening investigation will be performed for the identification of possible human specific metabolites. A successful execution of the of this project will enable the start of clinical Phase Ib in PD Patients, proof of concept studies in Phase II and bring the company into a situation where additional professionals and experts can be hired. The IRL790 project is a main part of the company´s core business and thus central in its strategy for sustained growth and financing.