IRLAB Therapeutics AB (Nasdaq Stockholm: IRLAB A) announced that all patients enrolled in the Phase IIb study with pirepemat (REACT-PD) have completed their final follow-up visits. The study is evaluating the drug candidate for its potential to reduce falls in patients with Parkinson's disease.
The Phase IIb study (IRL752C003 - REACT-PD) is a randomized, double-blind, placebo-controlled trial. It is designed to assess the efficacy, safety, and tolerability of two different doses of pirepemat compared to placebo in individuals with Parkinson's disease. The primary goal is to establish the optimal dose for a Phase III program.
The trial was conducted at clinics in France, Poland, the Netherlands, Spain, Sweden, and Germany. Patients underwent a one-month baseline period followed by three months of treatment with either placebo, 300 mg of pirepemat daily, or 600 mg of pirepemat daily, allocated in a 1:1:1 ratio. Follow-up visits were then conducted after the treatment period.
Addressing a Critical Unmet Need
Pirepemat aims to address the significant issue of falls in Parkinson's disease patients. Falls are a major cause of reduced quality of life, injuries, and increased mortality in this population. Currently, there are no approved medications specifically designed to reduce falls in Parkinson's disease, making pirepemat a potentially unique treatment option.
Kristina Torfgård, CEO of IRLAB, stated, "The completion of the final follow-up visit for patients in the Phase IIb study marks an important milestone in our clinical development program for pirepemat. We are delighted that as many as 87% of the enrolled patients completed the study indicating a low drop-out rate and that the participants enrolled in the current study are reported to be very satisfied during the treatment period. We now look forward to present topline results in the first quarter of 2025."
Preliminary Blinded Data
According to Joakim Tedroff, Chief Medical Officer at IRLAB, blinded data from the REACT-PD study suggests a reduction in the number of falls by approximately one-third compared to the baseline period. However, due to the double-blind nature of the study, it is not yet possible to determine the difference in effect between patients treated with pirepemat and those receiving placebo.
Mechanism of Action
Pirepemat (IRL752) is designed to enhance nerve cell signaling in the prefrontal cortex by acting as an antagonist at 5HT7 and alpha-2 receptors. This mechanism is intended to increase dopamine and noradrenaline levels in the brain. It is estimated that 45% of individuals with Parkinson's disease experience recurrent falls, impacting approximately 2.6 million people and significantly reducing their quality of life.
Following the completion of the study, data management, database locking, and analysis will be performed according to a predefined analysis plan. Topline results are expected in the first quarter of 2025. Additional information about the study can be found on EudraCT (2019-002627-16) and ClinicalTrials.gov (NCT05258071).
