#United States #New Haven #XingImaging #SynuSight #ABLi Therapeutics

Collaboration Overview

In a significant development for Parkinson's disease research, SynuSight Biotech, ABLi Therapeutics, and XingImaging have announced a strategic partnership designed to enhance clinical trial methodologies. This collaboration will introduce the novel alpha-synuclein PET imaging technique into the evaluation of risvodetinib, a new potential disease-modifying therapy for Parkinson's disease.

Key Components of the Collaboration

The three companies have entered into a non-exclusive licensing agreement. Under this arrangement, ABLi will use SynuSight's proprietary 18F-FD4 PET tracer, which is pivotal for visualizing alpha-synuclein pathology in the human brain, during their clinical trials.

XingImaging has been designated the U.S.-based manufacturer of FD4, integrating it with their advanced NeuroEXPLORER imaging system. This state-of-the-art device will be located at a new facility in New Haven, Connecticut, and is expected to enhance the effectiveness of the trials.

Clinical Trial Plans

ABLi intends to utilize 18F-FD4 in two upcoming clinical trials. The ABILITY-PD trial will focus on participants from a previous Phase 2a study, analyzing the efficacy of risvodetinib over the course of a year. This study will monitor various biomarkers across brain, blood, and tissue samples to assess treatment impact. Additionally, the CAMPD trial aims to evaluate the effectiveness of risvodetinib in up to 500 untreated Parkinson's patients, utilizing a double-blind, placebo-controlled approach.

Insights from Company Leaders

Roger Fan, the CEO of SynuSight, emphasized that this collaboration marks a pivotal step in integrating molecular imaging with clinical trials. He stated, "The partnership aims to interrogate the disease-modifying potential at the pathological level."

Dr. Milton Werner, Chairman and CEO of ABLi, mentioned the significance of adding PET imaging to the panel of biomarkers, stating, "This will expand our understanding of the disease-modifying effect of risvodetinib in Parkinson's disease."

Gilles Tamagnan, CEO of XingImaging, expressed confidence in the partnership's potential to advance significant diagnostic and treatment opportunities for Parkinson's patients.

About Risvodetinib and 18F-FD4

Risvodetinib is a cutting-edge small-molecule inhibitor targeting c-Abl kinases, designed for once-daily oral administration. It seeks to interrupt the biological processes that lead to the onset and progression of Parkinson's disease, representing a potential game-changer in treatment options.

18F-FD4, developed by SynuSight, is a high-affinity PET tracer crucial for imaging pathological α-synuclein in diseases related to Parkinson's. This tracer has exhibited remarkable efficiency in penetrating the blood-brain barrier and producing clear imaging results, reinforcing its role as a valuable tool for clinical evaluation.

Future Implications

The collaboration between SynuSight, ABLi, and XingImaging not only aims to refine treatment methods for Parkinson's disease but also showcases the potential for innovative imaging techniques in clinical research. With trials set to commence in 2026, the hope is to pave the way for more effective and disease-modifying therapies for millions affected by Parkinson's disease globally.

With the integration of advanced imaging capabilities within rigorous clinical trials, this partnership could lead to a deeper understanding of Parkinson's mechanisms and ultimately transform therapeutic approaches for patients around the world.