IRL757, potential 1st apathy treatment, begins Phase 1 testing
Trial to evaluate safety, efficacy in healthy volunteers
Dosing has begun in a Phase 1 clinical trial evaluating the safety and efficacy of IRL757, an oral candidate for apathy treatment in people with Parkinson’s disease and other neurological conditions.
Irlab Therapeutics, the therapy’s developer, recently announced the trial’s launch following approval by the Swedish Medical Products Agency. The Michael J. Fox Foundation for Parkinson’s Research has awarded the company a 20 million SEK (about $1.8 million) grant to support the study, which is expected to wrap up by the end of the year.
“We are very pleased to be able to start the clinical program with our drug candidate IRL757 so soon after the Medical Products Agency’s approval,” Joakim Tedroff, MD, PhD, Irlab’s chief medical officer, said in a company press release.
IRLAB also has a collaboration with McQuade Center for Strategic Research and Development, LLC (MSRD), part of Otsuka, to further develop IRL757.
“Our recently established development collaboration with MSRD/Otsuka and the extensive research support we receive from The Michael J. Fox Foundation are clear evidence that world-leading external assessors share our confidence in the potential of IRL757 to treat apathy, a condition affecting millions of people living with neurodegenerative diseases,” Joakim said.
No approved treatment for apathy
Apathy, characterized by indifference and resignation, is thought to affect over 20 million people in the U.S. and Europe, particularly among people with Parkinson’s and other neurological conditions, such as Alzheimer’s disease. There are no approved therapies to treat apathy.
According to Irlab, IRL757 has shown promising results in preclinical models that examined different aspects of cognitive function and motivation. Scientists believe the therapy reverses disrupted nerve signaling, which is thought to contribute to apathy in neurological disorders.
The Phase 1 study is enrolling healthy volunteers to evaluate IRL757’s safety, tolerability, and pharmacokinetics, or how the medicine moves into, through, and out of the body. Participants will receive single ascending doses in the first part, and multiple ascending doses in the second half. The impact of food intake will also be gauged.
In collaboration with MSRD/Otsuka, Irlab has secured full financing for clinical proof-of-concept studies and will retain full ownership and all patent rights to IRL757 during the collaboration period. Irlab is also entitled to an upfront payment of $3 million as well as potential milestone payments totaling $5.5 million. MSRD can extend the collaboration if certain triggering events are reached, but only after negotiating a new agreement.
In addition to IRL757, Irlab is developing mesdopetam (IRL790), its experimental oral treatment to ease levodopa-induced dyskinesia, the uncontrolled, involuntary movements common among Parkinson’s patients undergoing treatment.
Data from a Phase 2b study (NCT04435431) showed that a high dose of mesdopetam led to a clinically meaningful reduction in levodopa-induced symptoms. Mesdopetam was also found to reduce signs of psychosis, a common nonmotor symptom of Parkinson’s, in a rat model. The company is now preparing a Phase 3 clinical trial of mesdopetam.
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