IRLAB’s drug candidate IRL757 is Phase I ready

December 21, 2023

Gothenburg, Sweden, December 21, 2023 – IRLAB Therapeutics AB (Nasdaq Stockholm: IRLAB A), a company discovering and developing novel treatments for Parkinson’s disease, today announced that the company’s drug candidate IRL757 has completed all preclinical studies and development work necessary to start Phase I. All documentation is currently being prepared in a Phase I clinical trial application to be submitted for regulatory approval.

Gothenburg, Sweden, December 21, 2023 – IRLAB Therapeutics AB (Nasdaq Stockholm: IRLAB A), a company discovering and developing novel treatments for Parkinson’s disease, today announced that the company’s drug candidate IRL757 has completed all preclinical studies and development work necessary to start Phase I. All documentation is currently being prepared in a Phase I clinical trial application to be submitted for regulatory approval.

“Apathy is a debilitating condition in many neurological disorders and lacks effective treatment. IRL757 has shown tremendous potential in this indication in the preclinical program, and we are pleased that it is now ready for Phase I. Bringing yet another program to this stage shows the strength and ability of IRLAB to discover and develop novel therapies for neurological disorders,” said Gunnar Olsson, CEO, IRLAB.

IRLAB’s drug candidate IRL757 is being developed as a treatment for apathy in Parkinson’s and other neurological disorders with a once-daily oral administration. Apathy is a condition affecting over 20 million people in the US and Europe. IRL757 has a unique pharmacology that reverses the state of disruption in cortical to sub-cortical nerve signaling, a proposed mechanism underlying apathy in neurological disorders.

About IRL757

The drug candidate IRL757 is being developed as a treatment for apathy in Parkinson's disease and other neurological conditions. Apathy, a widespread and debilitating issue, affects over 20 million people in the U.S. and Europe alone without a currently available treatment. The prevalence is high, occurring in 1.1-4 million people (20–70 percent) being treated with Parkinson’s in the eight major markets (China, EU5, Japan, and the US), and in 4.9-6.7 million people (43–59 percent) being treated for Alzheimer’s disease in the ten major markets (Canada, China, EU5, Japan, South Korea, and the US).

RL757 has the potential to become the first treatment for apathy. IRL757 has shown promising results in various preclinical models, which assess different aspects of cognitive function and motivation. The observed efficacy of IRL757 is thought to be linked to its unique ability to reverse disruption in cortical to sub-cortical nerve signaling, a key factor believed to contribute to apathy in neurological disorders. IRL757 is considered Phase I ready as all preclinical studies and development work necessary to start Phase I is completed. A clinical trial application (CTA) to start a Phase I study is currently in preparation.

About IRLAB

IRLAB is discovering and developing a portfolio of transformative therapies targeting all stages of Parkinson’s disease. The company has its origin in Nobel Laureate Prof. Arvid Carlsson’s research group and the discovery of a connection between the brain’s neurotransmitters and CNS disorders. Mesdopetam (IRL790), in development for the treatment of levodopa-induced dyskinesias, has completed Phase IIb and is in preparation toward Phase III. Pirepemat (IRL752), is currently in Phase IIb, being evaluated for its effect on balance and fall frequency in Parkinson’s disease. In addition, the company is also progressing the three preclinical programs IRL942, IRL757, and IRL1117 towards Phase I studies. The pipeline is driven by IRLAB’s proprietary systems biology-based Integrative Screening Process (ISP) research platform. Headquartered in Sweden, IRLAB is listed on Nasdaq Stockholm (IRLAB A). For more information, please visit www.irlab.se.

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IRLAB’s drug candidate IRL757 is Phase I ready

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