Positive Data from the First Part of IRLAB’s Phase I Study with the Drug Candidate IRL757

GOTHENBURG, SE / ACCESSWIRE / October 3, 2024 / IRLAB Therapeutics (STO:IRLAB-A)(FRA:6IRA) Gothenburg, Sweden, October 3 2024 – IRLAB Therapeutics AB (Nasdaq Stockholm: IRLAB A) – a company discovering and developing novel treatments for Parkinson’s disease – today announces that the company has successfully completed the first part of its Phase I clinical trial with single ascending doses (SAD) of the drug candidate IRL757, which is being developed for the treatment of apathy. The results show that IRL757 is well absorbed, provides good exposure in the body and has a good tolerability and safety profile. IRLAB has recently secured full funding for the project through clinical proof-of-concept studies.

“We are very pleased to see that our drug candidate IRL757 is well absorbed, provides good exposure in the body and has a favorable 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,” says Dr. Joakim Tedroff, Chief Medical Officer, IRLAB.

IRLAB will now proceed with the second part of the study, in which the study participants will receive multiple ascending doses (MAD). The study program is expected to be fully completed in 2024.

The Phase I study is funded by The Michael J. Fox Foundation for Parkinson’s Research (MJFF) through a grant of approximately SEK 20 million. MJFF is the world’s largest non-profit funder of Parkinson’s disease research, and the organization’s support of IRL757 provides a strong external validation of the project’s potential.

In the spring of 2024, IRLAB entered a collaboration with MSRD, a part of the global pharmaceutical company Otsuka, to further develop IRL757. In this collaboration, the parties jointly design studies and activities, which IRLAB conducts while MSRD/Otsuka funds the project through “proof of concept” in selected larger patient populations.

About the Phase I study
The Phase I study consists of two parts and aims to document the safety, tolerability and pharmacokinetic properties of IRL757 in healthy subjects. In the first part of the study, single ascending doses of the drug candidate are administered (SAD) and in the second part, multiple ascending doses are given (MAD). In addition, the possible influence of concomitant food intake will be documented. The study is expected to be fully completed by the end of 2024 and top-line results are expected to be presented in the first quarter of 2025.