IRLAB Therapeutics has successfully completed the second and final part of its Phase I clinical study for IRL757, a novel drug candidate being developed to treat apathy in neurodegenerative diseases. The multiple ascending dose (MAD) portion of the trial demonstrated that IRL757 is well absorbed and provides good exposure in the body following ten days of dosing, with all participants completing the study and no serious adverse events recorded.
Strong Safety and Pharmacokinetic Profile Supports Advancement
The Phase I study results show that IRL757 demonstrates excellent tolerability and a favorable safety profile while achieving good systemic exposure. Dr. Joakim Tedroff, Chief Medical Officer at IRLAB, emphasized the significance of these findings: "We are very pleased that IRL757 is well absorbed and provides good exposure in the body while demonstrating excellent tolerability and a favorable safety profile. These results give us a strong foundation for the continued clinical development of the drug candidate, which has the potential to treat and counteract apathy in millions of patients with neurodegenerative diseases."
The comprehensive Phase I study consisted of two parts designed to document the safety, tolerability and pharmacokinetic properties of IRL757 in healthy subjects. The first part administered single ascending doses (SAD), while the recently completed second part evaluated multiple ascending doses (MAD). The study also documented the possible influence of concomitant food intake on the drug's properties.
Addressing a Significant Unmet Medical Need
Apathy represents a substantial unmet medical need in neurodegenerative diseases, characterized by indifference, resignation and a lack of response to external stimuli. The condition often leads to significant disability and caregiver distress, affecting a substantial proportion of people living with Parkinson's disease, Alzheimer's disease and other central nervous system disorders. Currently, there are no drugs on the market to treat apathy.
The prevalence of apathy is particularly high among patients with neurodegenerative diseases. In Parkinson's disease, apathy affects 1.1-4 million people (20-70 percent) being treated in the eight major markets including China, EU5, Japan, and the United States. Among Alzheimer's disease patients, the condition affects 4.9-6.7 million people (43-59 percent) being treated in the ten major markets, which include Canada, China, EU5, Japan, South Korea, and the United States. Overall, apathy affects over 20 million people in the U.S. and Europe alone.
Unique Mechanism of Action and Preclinical Promise
IRL757 has demonstrated positive effects in several preclinical models of cognitive function, including improved motivation. The drug candidate's efficacy is believed to be associated with its unique ability to counteract disturbances in central nervous system nerve signaling proposed to underlie apathy in several neurological conditions. Specifically, IRL757 has the potential to reverse disruption in cortical to sub-cortical nerve signaling, a key factor believed to contribute to apathy in neurological disorders.
Strategic Partnerships and Funding Support
The Phase I study received significant financial backing from The Michael J. Fox Foundation for Parkinson's Research (MJFF) through a grant of just over SEK 20 million. MJFF is recognized as the world's largest non-profit funder of Parkinson's disease research, and the organization's support for IRL757 represents strong external validation of the project's goals and therapeutic potential.
Building on the positive Phase I results, IRLAB has initiated a clinical Phase Ib study in Parkinson's disease and apathy in cooperation with The McQuade Center for Strategic Research and Development (MSRD), a member of the global Otsuka family of pharmaceutical companies. The first patients are expected to be enrolled in this proof-of-concept study in the second half of 2025. This collaboration, formed in May 2024, aims to advance IRL757 through proof-of-concept trials as a potential treatment for apathy.
Potential First-in-Class Treatment
IRL757 has the potential to become the first approved treatment for apathy, representing a significant breakthrough for patients with neurodegenerative diseases and their caregivers. The successful completion of Phase I studies with positive safety, tolerability and pharmacokinetic results provides a strong foundation for continued clinical development of this promising therapeutic candidate.
