Pharma Focus Europe

IRLAB Granted Approval by Swedish Medical Products Agency for Phase I Trial of IRL757 Drug Candidate

Monday, May 06, 2024

IRLAB Therapeutics AB (Nasdaq Stockholm: IRLAB A) has recently received approval from the Swedish Medical Products Agency to commence a Phase I clinical trial for their potential treatment for Parkinson’s disease, IRL757. This drug candidate aims to address apathy, a condition prevalent in Parkinson's disease, Alzheimer's disease, and other CNS disorders, impairing the quality of life for millions worldwide. The study, fully funded by The Michael J. Fox Foundation for Parkinson’s Research, underscores the shared optimism in IRL757's potential to combat apathy.

Apathy, characterized by indifference and disengagement, significantly impacts those with neurological diseases and their caregivers. Currently, there are no approved medications for apathy. IRL757 has shown promise in preclinical studies, demonstrating improved motivation and cognitive function. Its mechanism targets disruptions in nerve signaling between the cerebral cortex and deeper brain regions, believed to contribute to apathy onset.

The Phase I trial, funded by a grant from MJFF, will assess IRL757's safety, tolerability, and pharmacokinetics in healthy individuals. Divided into single and multiple ascending dose parts, the study will also explore the influence of food intake. Anticipated to conclude by the end of 2024, with top-line results expected in Q1 2025, this trial marks a significant step in addressing the unmet medical need in neurodegenerative diseases.

IRL757 is a potential treatment for apathy in Parkinson's disease and other neurological conditions, with over 20 million affected individuals in the U.S. and Europe alone. Prevalence rates are high, affecting a substantial proportion of patients undergoing treatment for Parkinson’s and Alzheimer’s diseases. With its unique mechanism targeting disrupted nerve signaling, IRL757 offers hope as the first apathy treatment. Having demonstrated efficacy in preclinical models, it is poised for Phase I trials following completion of all necessary preclinical studies and development work.



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