ABLi Therapeutics has completed a detailed biomarker analysis of risvodetinib for Parkinson’s disease (PD) covering 7,300 individual metrics from up to 80 participants in the Phase II 201 Trial.
The findings suggest that once-daily risvodetinib impacts several biological processes associated with PD.
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ABLi chairman and CEO Dr Milton Werner said: “The analysis of tissue, blood and spinal fluid measures from participants in the 201 Trial has revealed surprising information, both about the underlying processes of disease and how patients respond to risvodetinib treatment.
“The outcomes indicate that the biological cascade of disease is reflected by these biomarkers and is substantially reversed in 12-weeks of once daily treatment with risvodetinib, including substantial reduction in phosphorylated alpha-synuclein, believed to be the causative agent of human PD. In our view, this is how ‘disease-modification should look.”
The study considered the effect of risvodetinib on 11 markers tied to neuronal degeneration, mitochondrial function, and neuroinflammation. Participants received 50mg, 100mg or 200mg doses of risvodetinib once a day.
According to the data, all three doses inhibited cellular abelson tyrosine kinase (c-Abl) kinase, the study’s target.
The 100mg and 200mg doses reduced levels of phosphorylated alpha-synuclein in spinal fluid, while all doses reduced this biomarker in blood samples.
ABLi Therapeutics stated that these results support further investigation of the 100mg and 200mg doses in upcoming BASE, ABILITY and CAMPD studies.
The analysis also confirmed that risvodetinib suppressed indicators of neuroinflammation, including NOD-like Receptor Family Pyrin Domain Containing 3 (NLRP3), as well as the cytokines interleukin-1 beta (IL-1beta) and IL-18, reducing them below baseline levels in trial participants.
ABLi Therapeutics is exploring further use of these biomarkers in its CAMPD trial, which aims to examine how these biomarker changes relate to clinical outcomes in people with PD.
Risvodetinib is a selective small-molecule inhibitor targeting c-Abl kinases, intended for oral dosing once per day, and is designed to impact the mechanisms underlying PD.
