Potential oral therapy for apathy to enter clinical trial in patients
Phase 1b safety, early efficacy trial of IRL757 may start enrolling this year
Irlab Therapeutics is moving its oral candidate, IRL757, into a Phase 1b clinical study to assess its safety and explore early signs of efficacy in treating apathy in people with Parkinson’s disease. Patient enrollment is expected to begin in the second half of 2025.
Financial support for the trial was given by the McQuade Center for Strategic Research and Development (MSRD) through an initial payment of $4.5 million. Part of the pharmaceutical company Otsuka, MSRD supports early-stage work into potential treatments for neurological and renal disorders, and it collaborated with Irlab last year to advance IRL757 into clinical studies.
“We are excited to continue our collaboration with MSRD … with a study aiming to find early signals of efficacy in Parkinson’s patients suffering from apathy. The scientific and financial support from our partner enables us to continue the development of this first-in-class drug candidate at high speed,” Kristina Torfgård, CEO of Irlab, said in a company press release.
Apathy is estimated to affect sizable portions of Parkinson’s patients
Apathy is a challenging nonmotor symptom of Parkinson’s that diminishes motivation and engagement, significantly affecting patients’ quality of life.
Characterized by indifference and resignation, it can interfere with daily activities and make it harder to manage other symptoms, as those affected are less likely adhere to their medication schedules and exercise as recommended. People with apathy also may be dealing with depression.
Apathy affects over 20 million people in the U.S. and Europe, Irlab reports, including 20% to 70% of Parkinson’s patients in “major markets” like the U.S., European Union, China and Japan. It is also estimated globally to affect up to 59% of people with Alzheimer’s, another neurodegenerative disease. As with Parkinson’s treatments, those approved for Alzheimer’s largely target disease symptoms.
IRL757 is thought to address apathy by restoring disrupted nerve signaling between the cerebral cortex — the brain’s outer layer that’s responsible for regulating thoughts, emotions, and behaviors — and deeper brain regions. This dysfunction is believed to contribute to apathy in neurological disorders.
Irlab’s decision to advance its candidate into a Phase 1b clinical trial is supported by results from two recent Phase 1 studies (NCT06493045 and NCT06699628). These studies involved healthy volunteers and adults ages 65 and older, evaluating the pharmacokinetics, or how a compound moves through the body, and the safety and tolerability of increasing oral doses of IRL757.
Results demonstrated that IRL757 was well absorbed, widely distributed in the body, and had a favorable safety profile without the occurrence of serious adverse events.
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