IRLAB Therapeutics AB announced that Pirepemat has the potential to become the first treatment for the largest unmet need in Parkinson's, prevention and reduction of falls and fall injuries, and is in the forefront of the treatment of falls in Parkinson's. The ongoing pioneering Phase IIb study, React-PD has already generated invaluable new knowledge about the specific group of recurrent fallers. Baseline fall rates show that subjects enrolled in the study fall 2-3 times more than previously anticipated, providing a higher probability to observe treatment dependent effects. Enrollment of study subjects has been ongoing at all study sites since May 2023, and the enrollment rate has stabilized.

Based on the new information, IRLAB is able to more accurately predict the enrollment timelines for the remainder of the React-PD study, now anticipating that study enrollment will be completed in the third quarter 2024. The ongoing pioneering Phase IIss study, React-PD, in people at more advanced stages of Parkinson's disease evaluates effects of pirepemat with the main objective to identify the optimal dose for Phase III. The React-PD study has been running with all 38 clinics activated since May 2023, and The enrollment of patients is now progressing at a steady pace.

Factors influencing the initial enrollment rate are, among others, the logistical support needed for study subjects to make visits to the clinics and the relatively large number of visits during the study. Baseline data in the React-PD study also show that subjects fall 2-3 times more often than anticipated. Further, the individual fall rates are stable during the one-month study run-in before starting study medication.

Combined, this provides a higher likelihood to detect treatment-dependent effects on fall rates. These observations, in combination with lower drop-out rates than anticipated, have prompted IRLAB to initiate discussions to submit a study amendment with a reassessment of the sample size for the study. Thus, it is possible that the planned study sample size can be reduced with retained power of the study, i.e., its potential to detect a treatment-dependent effect on fall rate.

Based on the experience from the React-PD study, IRLAB now have compiled information regarding this specific patient population, enabling more accurate data driven predictions of enrollment rate and study timelines. Based on the new data obtained from this specific patient population, the Company now anticipates that study enrollment will be completed In the third quarter 2024. The Phase IIb study of pirepemat (IRL752C003 - React PD) is a double blinded and placebo-controlled Phase IIb study with the aim to evaluate the effect of pirepemat on falls frequency in people with Parkinson's, at two dose levels and placebo over a three-month treatment period.

The secondary study objectives include cognitive and neuropsychiatric assessments and further safety and tolerability studies. The study comprises two groups with different dose levels of pirepemat and one placebo group. The ongoing study is recruiting patients at the planned sites in France, Germany, the Netherlands, Poland, Spain and Sweden.

The company's assessment is that patient recruitment to the study will be completed during the third quarter of 2024. This is followed by a one month baseline period, a three month baseline period, a three-month treatment period of 2024.