IRLAB reports positive results from the second part of a Phase I study with IRL757
Prenumeration
Beskrivning
| Land | Sverige |
|---|---|
| Lista | Small Cap Stockholm |
| Sektor | Hälsovård |
| Industri | Bioteknik |
Gothenburg, Sweden, May 28, 2025 - IRLAB Therapeutics AB (Nasdaq Stockholm: IRLAB A), a company that discovers and develops new treatments for Parkinson's disease, today announces the company has successfully completed the second and final part of its clinical Phase I study, in which the drug candidate IRL757, being developed for the treatment of apathy, was administered in multiple ascending doses (MAD). The results show that IRL757 is well absorbed and provides good exposure in the body following ten days of dosing. All participants completed the study, and no serious adverse events were recorded. The safety, tolerability and pharmacokinetic profile of IRL757 support continued clinical development.
"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,” says Dr. Joakim Tedroff, MD, Chief Medical Officer at IRLAB.
The Phase I study has been funded by The Michael J. Fox Foundation for Parkinson's Research (MJFF) through a grant of just over SEK 20 million. MJFF is the world's largest non-profit funder of Parkinson's disease research, and the organization's support for IRL757 means a strong external validation of the project's goals and potential.
Based on the positive results from the completed Phase I studies, a clinical Phase Ib study in Parkinson's disease and apathy has been initiated 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 the study in the second half of 2025. IRLAB and MSRD formed a collaboration in May 2024 to advance IRL757 through proof-of-concept trials as a potential treatment of apathy.
Apathy is characterized by indifference, resignation and a lack of response to what is happening in the outside world. The condition often leads to significant disability and caregiver distress, affecting a substantial proportion of people living with Parkinson's, Alzheimer's 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 proposed to underly apathy in several neurological conditions.
Om Fas I-studien
The Phase I study consists of two parts and aims to document the safety, tolerability and pharmacokinetic properties of IRL757 in healthy subjects. In the first part of the study, single ascending doses of the drug candidate are administered (SAD) and in the second part, multiple ascending doses are given (MAD). In addition, the possible influence of concomitant food intake will be documented.