Drug candidate IRL757 originate from the P001 research program and aims to treat apathy in neurological disorders. The candidate is in Phase I.

IRL757 is in clinical development and aims at a once daily oral tablet to treat apathy in Parkinson’s and other neurological disorders. Apathy is a debilitating condition affecting over 10 million people in the US and equally many in Europe. The prevalence is high, occurring in 20–70 percent of people with Parkinson’s and in 20–90 percent of people with disorders such as Alzheimer’s disease and other disorders related to CNS.

Preclinical efficacy by IRL757 has been obtained in several pre-clinical models representing various aspects of cognitive function including potential signals of improved motivation. The efficacy by IRL757 observed, is hypothesized to be associated with IRL757’s unique pharmacology to reverse disruption in cortical to sub-cortical nerve signaling, a proposed mechanism underlying apathy in neurological disorders.

Non-clinical development activities related to CMC, toxicology and safety studies to prepare for regulatory submission to start Phase I studies has been finalized and a Phase I study started in the end of May 2024.

In the end of 2023, IRLAB was awarded a grant of over SEK 20 million from The Michael J. Fox Foundation, the largest not-for-profit organization for supporting Parkinson’s research, to finance the Phase I program and in May 2024 a research collaboration was announced with MSRD, part of the Otsuka family of companies, where MSRD/Otsuka will finance the development of IRL757 through clinical Proof-of-Concept.