IRLAB Approved by Swedish Agency for Phase I Study of IRL757

GOTHENBURG, SWEDEN – IRLAB Therapeutics AB, a prominent organization in the discovery and development of new treatments for Parkinson's disease, has received approval from the Swedish Medical Products Agency to commence a Phase I clinical trial of their drug candidate, IRL757. This drug is being developed as a potential treatment for apathy, a condition that significantly affects the quality of life for individuals with Parkinson's disease, Alzheimer's disease, and other central nervous system (CNS) disorders. This Phase I study is financially supported by The Michael J. Fox Foundation for Parkinson's Research, the largest non-profit funder of Parkinson's research globally.

Dr. Joakim Tedroff, Chief Medical Officer of IRLAB, expressed optimism about the positive feedback from the Swedish Medical Products Agency and the upcoming initiation of the clinical study. The substantial financial backing from The Michael J. Fox Foundation underscores the confidence of global experts in the potential of IRL757 to address apathy, a condition currently without any approved treatments. This condition, characterized by indifference and lack of response to surroundings, results in substantial disability in individuals with neurodegenerative diseases, impacting millions and their families.

Apathy, marked by indifference and lack of reaction to environmental stimuli, often brings about severe disability. It affects a large portion of individuals with Parkinson's, Alzheimer's, and other CNS-related diseases. Despite its prevalence, there are no available treatments for apathy. IRL757 has shown promise in preclinical models for enhancing cognitive function and motivation. Its unique mechanism is believed to counteract disruptions in nerve signaling between the cerebral cortex and deeper brain regions, disruptions that are thought to cause apathy in several neurological conditions.

The Phase I clinical trial will be divided into two parts. The primary goal is to document the safety, tolerability, and pharmacokinetic properties of IRL757 in healthy volunteers. The first segment will involve Single Ascending Doses (SAD) of the drug candidate, while the second segment will involve Multiple Ascending Doses (MAD). The trial will also evaluate the potential impact of food intake on the drug's properties. This study is expected to be completed by the end of 2024, with top-line results anticipated in the first quarter of 2025.

The Michael J. Fox Foundation has provided a grant of approximately SEK 20 million for this Phase I trial of IRL757. Recognized as the largest non-profit funder of Parkinson's disease research in the world, the foundation's endorsement provides strong external validation of IRL757's potential.

IRL757 aims to become the first approved treatment for apathy. Preclinical studies have shown that IRL757 can significantly improve cognitive function and motivation by addressing disruptions in nerve signaling pathways, a key factor in the development of apathy in CNS disorders. With all necessary preclinical studies and development work completed, IRL757 is ready for Phase I clinical trials.

IRLAB Therapeutics, founded on the pioneering research of Nobel Laureate Prof. Arvid Carlsson, focuses on discovering and developing innovative therapies for Parkinson's disease. Their portfolio includes Mesdopetam (IRL790), moving toward Phase III development for levodopa-induced dyskinesias, and Pirepemat (IRL752), in Phase IIb for evaluating effects on balance and fall frequency in Parkinson's disease patients. In addition to IRL757, which is supported by The Michael J. Fox Foundation, IRLAB is advancing other preclinical programs such as IRL942 and IRL1117 towards Phase I studies. The company's pipeline is developed through their proprietary Integrative Screening Process (ISP) research platform. IRLAB is headquartered in Sweden and listed on Nasdaq Stockholm (IRLAB A).