Linepemat (IRL757)

Drug candidate linepemat (IRL757) aims to treat apathy in Parkinson’s and other neurological disorders. Apathy is a debilitating condition affecting millions of people living with neurological conditions across the globe. Linepemat is currently in Phase Ib clinical development, with an ongoing study in patients with Parkinson’s disease and apathy funded by the global pharmaceutical company Otsuka.

Linepemat 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 which equates to 1.1-4.0 million people on the eight major markets. Apathy is also prevalent in 43–59 percent of people being treated for Alzheimer’s disease, equates to 4.9-6.7 million people in the ten major markets globally (Canada, China, France, Germany, Italy, Japan, Spain, South Korea, the UK and the US).  

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

In the spring of 2024, the drug candidate linepemat received approval from regulatory authorities to begin Phase I after successfully completing the required preclinical studies and development work. In the first Phase I clinical study the drug candidate linepemat was administered in ascending doses (Single Ascending Dose, SAD) and repeated and ascending doses are administered (Multiple Ascending Dose, MAD). The results show that linepemat is well absorbed, provides good exposure in the body and has a favourable tolerability and safety profile. The SAD and MAD study is carried out with funding from the Michael J. Fox foundation. In parallel an additional Phase I clinical study with linepemat was initiated, in a group of research subjects aged 65 and over. The results show that linepemat is well absorbed and provides good exposure in the body also in this age group. This study in the elderly is the first clinical study within the framework of the collaboration with Otsuka.

Results from the preclinical and Phase I clinical studies demonstrated that linepemat is well absorbed following oral administration, provides favorable systemic exposure, and has a favorable safety and tolerability profile. Taken together, the safety, tolerability, and pharmacokinetic data support the continued development of linepemat.

In December 2025, the Company received approval from the European Medicines Agency (EMA) to conduct the LIFT-PD study. The study was initiated in 2025, and the first patients were recruited and dosed during early 2026.

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. In May 2024, IRLAB also entered a research collaboration was entered with Otsuka, a global pharmaceutical company, which will finance the development of linepemat through clinical Proof-of-Concept for the treatment of apathy in both Parkinson’s and Alzheimer’s.