IRLAB Therapeutics

The single-center, open-label, phase I study evaluates the pharmacokinetics, safety and tolerability of single ascending oral doses of IRL757 in healthy individuals aged 65 and older. The study is expected to be completed in the end of Q4 2024.

"We are very pleased to continue the clinical development with IRL757 with a study in healthy older adults. IRL757 is a new first-in-class drug candidate for apathy, a condition affecting millions of people living with neurodegenerative diseases, most of which are elderly," says Dr. Joakim Tedroff, MD, Chief Medical Officer, IRLAB.

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 caregiver distress affecting 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 central nervous system nerve signaling believed to be an underlying cause of apathy in several neurological conditions.

In parallel with the study in healthy adults aged 65 and older, IRLAB is conducting a Phase I study consisting of two parts to document the safety, tolerability, and pharmacokinetic properties of IRL757 in healthy younger subjects. This study is expected to be fully completed in 2024 and is funded by The Michael J. Fox Foundation for Parkinson's Research (MJFF).

Under the current collaboration with McQuade Center for Strategic Research and Development, LLC (MSRD), IRLAB has received 3 million USD in up-front payment and can receive an additional 5.5 million USD following the achievement of certain development milestones. MSRD will also fund the drug development activities during the term of the agreement, with the exception of the currently ongoing Phase I program in healthy younger subjects, funded by The Michael J. Fox Foundation.

Further, under the terms of the current collaboration agreement, MSRD has the opportunity to elect to expand the collaboration upon the occurrence of certain triggering events, subject to negotiations of a new agreement. MSRD might also, if the parties do not expand the collaboration, under certain circumstances receive low single-digit percentage royalty payments.