IRLAB has activated all 38 study sites in the Phase IIb study of pirepemat aiming to improve balance and reduce falls in Parkinson’s disease

May 31, 2023

Gothenburg, Sweden, May 31, 2023 – IRLAB Therapeutics AB (Nasdaq Stockholm: IRLAB A), a company discovering and developing novel treatments for Parkinson’s disease, today announced that all participating study sites in the Phase IIb study of pirepemat (IRL752) are activated and recruiting patients. The study is conducted at 38 study sites across six European countries. Pirepemat has the potential to become the first treatment in a new class of drugs designed to improve balance and reduce falls and fall injuries in people living with Parkinson’s disease.

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Gothenburg, Sweden, May 31, 2023 – IRLAB Therapeutics AB (Nasdaq Stockholm: IRLAB A), a company discovering and developing novel treatments for Parkinson’s disease, today announced that all participating study sites in the Phase IIb study of pirepemat (IRL752) are activated and recruiting patients. The study is conducted at 38 study sites across six European countries. Pirepemat has the potential to become the first treatment in a new class of drugs designed to improve balance and reduce falls and fall injuries in people living with Parkinson’s disease.

The Phase IIb study of pirepemat is a randomized, double-blind, and placebo-controlled study with the aim to evaluate the effect of pirepemat on falls frequency, postural dysfunction, cognitive function, symptoms of Parkinson’s disease as well as safety and tolerability, in people with Parkinson’s disease. The study is active at 38 study sites across France, Germany, Poland, the Netherlands, Spain, and Sweden. Patient recruitment and randomization are expected to be completed by the year-end of 2023 followed by the three-month treatment period, follow-up visits, data management, and database lock. Top-line results are further expected in H1 2024.

“We are making good progress with the Phase IIb study of pirepemat and predict a steady recruitment pace over the coming period as the study is now fully up and running. I am particularly pleased to have Prof. Bastiaan Bloem, one of the world’s leading experts on impaired balance and falls in Parkinson’s disease and investigator in our study, start recruitment at the recently activated site in the Netherlands. He is a prominent voice in the Parkinson’s space with a deep commitment to finding a solution to the problem with falls in people living with Parkinson’s disease,” said Joakim Tedroff, CMO of IRLAB.

“Falls are a significant consequence of Parkinson’s disease that has severe complications of which fractures, impaired mobility, and reduced quality of life are the most burdensome,” said Nicholas Waters, EVP and Head of R&D of IRLAB. “There are no available treatments at present, despite the great medical need with nearly half of all people living with Parkinson’s disease falling recurrently. We believe pirepemat has the potential to make a real difference in the lives of people living with Parkinson’s disease and their families.”

More information will be shared as the study progresses, and further details about the Phase IIb study can be found on EudraCT number: 2019- 002627-16 and clinicaltrials.gov: NCT05258071.

For further information, please contact:
Nicholas Waters, EVP and Head of R&D
Phone: +46 730 75 77 01
E-mail: nicholas.waters@irlab.se

Joakim Tedroff, Chief Medical Officer (CMO)
Phone: +46 707 60 16 91
E-mail: joakim.tedroff@irlab.se

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, is the company’s most advanced program and was licensed to Ipsen in 2021. A second candidate, 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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