Bifogade filer
IRLAB provides additional efficacy data from the Phase IIb study of pirepemat in patients with Parkinson's disease
Prenumeration
Beskrivning
| Land | Sverige |
|---|---|
| Lista | Small Cap Stockholm |
| Sektor | Hälsovård |
| Industri | Bioteknik |
Gothenburg, Sweden, March 28, 2025 - IRLAB Therapeutics AB (Nasdaq Stockholm: IRLAB A), a company that discovers and develops new treatments for Parkinson's disease, today announces further results based on prespecified in-depth efficacy analyses of the data generated in the Phase IIb dose finding and efficacy study of pirepemat (REACT-PD). The analysis reveals that in a medium plasma concentration range, pirepemat reduced the fall rate by as much as 51.5% after three months of treatment. This effect is highly clinically meaningful and statistically significant (p<0.05 vs. placebo). Based on these compelling results, the company now continues with further analyses of the study data to reach a decision on how to best design forthcoming studies during the continued clinical development of the drug candidate.
The REACT-PD study in patients with Parkinson’s disease was recently completed. As part of the pre-specified analyses beyond topline data, the company has now investigated the relation between pirepemat exposure (i.e., plasma concentrations) and fall rate within the dose range used in the study. The results show that the relationship between exposure of pirepemat and the fall rate follows a biphasic pattern. Medium exposure of pirepemat reduces fall rates by 51.5 % at the end of the treatment period (p<0.05 vs. placebo over the treatment period) whereas high and low exposures do not lead to beneficial effects. Study participants from both the 600 mg and 300 mg daily cohorts are evenly distributed in the medium exposure group.
“The React-PD study is a pioneering dose finding Phase II study designed to provide information on the effects of pirepemat on fall rates in Parkinson’s disease, an area of investigation with little preceding data guiding investigators. The discovery of a clear plasma concentration dependent effect is very encouraging. In addition, the data generated also guides us on how to design future clinical trials with pirepemat, which is the purpose of Phase II studies. Based on the study results, it is clear to us that there is a way forward for pirepemat to address the largest unmet need in the treatment of Parkinson’s disease, says," says Kristina Torfgård, CEO of IRLAB.
“The statistically significant and highly clinically meaningful reduction of fall rate to 50% compared to baseline in the medium plasma concentration range of pirepemat is a very important finding in the React-PD study. It is very encouraging that we now have gained a deeper understanding of the exposure dependent efficacy profile of our drug candidate, also confirming that it affects the brain mechanisms involved in the systems controlling upright posture and stability leading to reduced fall rate,” comments Joakim Tedroff, Chief Medical Officer at IRLAB.
IRLAB thanks the patients and their caregivers for their trust and participation in this study. The company also extends its appreciations to the investigators, the CRO and the clinical development team for their diligent and hard work conducting the Phase IIb trial.
Webcast for investors, analysts and media
IRLAB will host a live webcast in connection with announcing the additional results from the Phase IIb study on March 28, 2025, at 13:30 CET.
Link to the webcast: https://youtube.com/live/yZWAEw9aRtE