IRLAB Therapeutics

Reviews by the independent safety committee, DSMB, are part of the study protocol for the Phase IIb study of pirepemat, IRL752C003 - React PD. This is the second and final safety and data integrity review of the study and, as on the first occasion in July 2023, the DSMB unanimously recommends that ReactPD can proceed under the approved study protocol without modifications.

"Following the positive opinion from the independent safety committee, DSMB, we can now complete the study in full accordance with the study protocol. Our aim is to always maintain the highest possible patient safety and a rigorous scientific approach, where DSMB reviews are an important part," says Gunnar Olsson, CEO of IRLAB.

A DSMB is an independent committee of experts responsible for reviewing clinical trial data on an ongoing basis during a study to ensure the safety of study participants and the validity and integrity of the data. The DSMB makes recommendations on the continuation, modification or termination of the clinical trial based on the results of the pre-specified data review.

The Phase IIb study of pirepemat (IRL752C003 - React PD) is a randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety and tolerability of different doses of pirepemat in people living with Parkinson's disease to determine the optimal dose for Phase III. In addition to safety and tolerability, the study aims to evaluate the effect of pirepemat on fall frequency, postural dysfunction, cognitive function, and symptoms of Parkinson's disease in people living with Parkinson's disease. The study is being conducted in clinics in France, Poland, the Netherlands, Spain, Sweden and Germany. Recruitment of patients is expected to be completed in the third quarter of 2024, followed by a three-month treatment period, follow-up visits, data management and database lock before top-line results can be presented.