"We are very pleased to be able to start the clinical program with our drug candidate IRL757 so soon after the Medical Products Agency's approval. Our recently established development collaboration with MSRD/Otsuka and the extensive research support we receive from The Michael J. Fox Foundation are clear evidence that world-leading external assessors share our confidence in the potential of IRL757 to treat apathy, a condition affecting millions of people living with neurodegenerative diseases," says Dr. Joakim Tedroff, MD, Chief Medical Officer, IRLAB.

The Michael J. Fox Foundation (MJFF) has awarded a grant of more than SEK 20 million to conduct this first Phase I clinical trial of IRL757. 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.

IRLAB has also recently announced a collaboration with McQuade Center for Strategic Research and Development, LLC (MSRD), part of the global pharmaceutical company Otsuka, to develop IRL757 further. By this, IRLAB has secured full financing of the project through clinical proof-of-concept studies. IRLAB retains full ownership and all patent rights to IRL757 during the collaboration period, and is also entitled to an upfront payment of USD 3 million as well as potential milestone payments totaling USD 5.5 million during the term of the agreement. According to the agreement, MSRD has the option to extend the collaboration upon the occurrence of certain triggering events, but only after negotiating a new agreement. If the parties choose not to extend the collaboration, MSRD may also, under certain circumstances, receive low single-digit percentage royalty payments.

Apathy is characterized by indifference, resignation and a lack of response to what is happening in the world around them. The condition often causes significant disability and affects a large proportion of people living with Parkinson's disease, Alzheimer's disease and other diseases related to the central nervous system. Currently, there are no drugs on the market to treat apathy.

IRLAB's drug candidate IRL757 has shown positive effects in several preclinical models of cognitive function, including improved motivation. This effect is believed to be associated with the drug candidate's unique ability to counteract disturbances in nerve signaling that are believed to cause apathy in several neurological diseases.

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, ascending doses of the drug candidate are administered (Single Ascending Dose, SAD), and in the second part, repeated and ascending doses are given (Multiple Ascending Dose, MAD). In addition, the possible influence of concomitant food intake will be documented. The study is expected to be fully completed in 2024.