IRLAB THERAPEUTICS AB The ongoing pioneering Phase IIb 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
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.
“Instability and falls are an important challenge in the treatment of Parkinson's disease, since they represent a problem that significantly affects patients' quality of life. Being able to participate in this study, with such an important goal, could help to improve this circumstance for many patients. Although it is a double-blinded phase II study, participating patients describe a relevant improvement in their general condition,“ said dr
“Participants enrolled in the study are reported to be highly satisfied during the study treatment period, which is further corroborated by repeated requests from patients and physicians for continued treatment beyond the clinical trial. I interpret this positive feedback from participants, caretakers, and treating physicians as a clear signal of the benefit of participating in this study,” said Joakim Tedroff, Chief Medical Officer IRLAB. “We continue to work closely with our CRO, the investigators, and participating clinics with the aim of optimizing outcomes and simplify for patients to enroll. This includes reducing the number of hospital visits by allowing home visits where applicable. We are, thus, confident with the updated timeline estimation given the steady enrollment pace and the lower drop-out rates in this study,” said Joakim Tedroff, Chief Medical Officer IRLAB.
“Based on what we have learned about pirepemat, we see a great possibility to have a first-in-class drug for the treatment of falls in Parkinson’s that can change the treatment algorithm to benefit patients and their families. I see a major commercial potential for pirepemat as it targets untreated symptoms and a high unmet need with a potential to decrease overall healthcare cost. The potential is further strengthened by the recently reported granted patent for pirepemat. We are looking forward to the completion of the study and to intensify our BD activities to identify partnership ahead of the Phase III program and the commercialization of the product,” said
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