IRLAB Administers First Dose in Phase I Trial for IRL757

IRLAB Therapeutics, a company based in Gothenburg, Sweden, which specializes in developing innovative treatments for Parkinson's disease, has commenced dosing in a Phase I clinical trial for their drug candidate IRL757. This advancement follows the approval from the Medical Products Agency. IRL757 aims to address apathy, a debilitating condition that hampers the quality of life for millions of individuals with Parkinson's disease and other central nervous system (CNS) disorders.

IRLAB's development of IRL757 is supported by a collaboration with MSRD/Otsuka and a substantial grant from The Michael J. Fox Foundation (MJFF). The latter, recognized as the world's largest non-profit funder of Parkinson's disease research, has contributed over SEK 20 million to this Phase I clinical trial. This backing underscores the potential seen in IRL757 by leading external evaluators.

Dr. Joakim Tedroff, Chief Medical Officer at IRLAB, expressed satisfaction with the swift initiation of the clinical program post-approval. He emphasized that the collaboration with MSRD/Otsuka and the significant support from MJFF are strong indicators of confidence in IRL757's capability to treat apathy, a common issue in neurodegenerative diseases.

IRLAB's collaboration with McQuade Center for Strategic Research and Development, LLC (MSRD), part of Otsuka, ensures comprehensive funding through to clinical proof-of-concept studies. During this period, IRLAB retains full ownership and patent rights for IRL757 and is set to receive an upfront payment of USD 3 million, along with potential milestone payments summing up to USD 5.5 million. The agreement allows MSRD the option to extend the collaboration based on certain conditions, with the possibility of future royalty payments under specific scenarios.

Apathy, characterized by indifference and a lack of engagement with one's surroundings, significantly impairs many people with Parkinson's disease, Alzheimer's disease, and other CNS conditions. Despite its prevalence, there are currently no approved drugs specifically targeting apathy. IRL757 has demonstrated positive effects in preclinical models, showing improvements in motivation and cognitive function. These benefits are thought to stem from the drug’s unique ability to counteract disruptions in nerve signaling, which are believed to be a cause of apathy in several neurological diseases.

The Phase I clinical trial for IRL757 consists of two parts. The first part involves escalating doses of the drug (Single Ascending Dose, SAD) administered to the participants. The second part involves repeated and increasing doses (Multiple Ascending Dose, MAD). Additionally, the trial will document the effects of food intake on the drug’s performance. The study is anticipated to be fully completed within 2024.

IRL757 is being developed to potentially become the first treatment specifically for apathy. This condition affects over 20 million people across the U.S. and Europe, with a notable prevalence among those treated for Parkinson's and Alzheimer's diseases. The drug has shown promising results in preclinical studies by improving cognitive functions and reversing disruptions in nerve signaling pathways.

IRLAB, originating from the research of Nobel Laureate Prof. Arvid Carlsson, is committed to discovering and developing transformative treatments for Parkinson's disease. The company’s pipeline includes other promising drugs like Mesdopetam (IRL790) and Pirepemat (IRL752), which are in advanced stages of clinical trials. Additionally, IRLAB has two preclinical programs, IRL942 and IRL1117, progressing towards Phase I studies. The company's research platform, Integrative Screening Process (ISP), has been instrumental in generating its robust drug pipeline. IRLAB is listed on Nasdaq Stockholm and headquartered in Sweden.