Phase 1 trial of IRL757 demonstrates good absorption and safety profile.

IRLAB Therapeutics AB has announced the successful completion of the first part of its Phase I clinical trial for IRL757, a drug candidate aimed at treating apathy in patients with Parkinson’s disease.

The results indicate that IRL757 is well absorbed, provides good exposure in the body, and has a favourable safety profile.

Dr Joakim Tedroff, Chief Medical Officer at IRLAB, expressed optimism about the findings, stating: “We are very pleased to see that our drug candidate IRL757 is well absorbed, provides good exposure in the body and has a favourable safety profile. This bodes well for the further clinical development of a potential treatment that can counteract the apathetic conditions that affect millions of patients with neurodegenerative diseases.”

The phase 1 study, funded by The Michael J. Fox Foundation for Parkinson’s Research (MJFF) with a grant of approximately SEK 20 million, is the largest non-profit funder of Parkinson’s disease research. The support from MJFF provides strong external validation of the project’s potential.

IRLAB will now proceed with the second part of the study, where participants will receive multiple ascending doses (MAD). The study program is expected to be fully completed in 2024, with top-line results anticipated in the first quarter of 2025.

In addition to the MJFF funding, IRLAB has entered a collaboration with MSRD, a part of the global pharmaceutical company Otsuka, to further develop IRL757.

This partnership involves jointly designing studies and activities, with MSRD/Otsuka funding the project through proof-of-concept in selected larger patient populations.

The phase 1 study aims to document the safety, tolerability, and pharmacokinetic properties of IRL757 in healthy subjects.

The drug candidate is being developed as a treatment for apathy in Parkinson’s disease and other neurological conditions, potentially becoming the first treatment for this widespread and debilitating issue.