IRLAB Therapeutics, a biotech company developing new treatments for Parkinson’s disease, has secured regulatory and ethical approvals to begin a Phase Ib study of its drug candidate, IRL757. 

 

The trial will evaluate safety, tolerability, and early efficacy signals in patients experiencing apathy, a condition that significantly impacts quality of life.

 

The multicenter study will enroll 75 patients across 16 sites in Germany, Bulgaria, Poland, and Spain. It is fully funded by IRLAB’s development partner, the McQuade Center for Strategic Research and Development (MSRD), an indirect subsidiary of Otsuka Pharmaceutical Co.

 

“We are excited about the Phase Ib Signal Finding Study of our drug candidate, IRL757, in Parkinson’s patients experiencing apathy. This condition causes significant disability for many individuals living with Parkinson's disease. 

 

"Currently, there is a substantial medical need for an effective treatment of apathy which lacks treatment options. With strong scientific and financial backing from our collaborator MSRD, we have developed this first-in-class drug candidate very efficiently,” said Kristina Torfgård, CEO of IRLAB.

 

IRL757 has already demonstrated promising results in two Phase I studies with healthy adults, showing good absorption and systemic exposure over 10 days of dosing, with no serious adverse events reported.

 

Apathy, characterized by indifference, resignation, and lack of response to external stimuli, affects a substantial proportion of people with Parkinson’s and other neurodegenerative diseases. No approved treatments currently exist.

 

IRLAB and MSRD formed a collaboration in May 2024 to advance IRL757 through proof-of-concept trials. Preclinical studies have shown that the drug candidate may improve cognitive function and motivation by counteracting disturbances in central nervous system signaling thought to underlie apathy.