SynuSight, ABLi Therapeutics, and XingImaging Partner to Advance Alpha-Synuclein PET Imaging in Parkinson's Disease Trials
核心洞察
SynuSight Biotech (搜索) has licensed its alpha-synuclein (搜索) PET tracer 18F-FD4 (搜索) to ABLi Therapeutics (搜索) for use in clinical trials evaluating risvodetinib as a disease-modifying therapy for Parkinson's disease (搜索).
ABLi plans to implement 18F-FD4 (搜索) in two 2026 clinical trials: ABILITY-PD, a 12-month biomarker study re-enrolling 120 Phase 2a participants, and CAMPD, a Phase 2b/3 trial with up to 500 untreated Parkinson's patients.
The collaboration integrates advanced PET imaging with XingImaging (搜索)'s ultra-high resolution NeuroEXPLORER brain imager to comprehensively evaluate risvodetinib's therapeutic effects on alpha-synuclein (搜索) pathology.
SynuSight Biotech (搜索), ABLi Therapeutics (搜索), and XingImaging (搜索) have announced a strategic collaboration to integrate alpha-synuclein (搜索) PET imaging into clinical trials evaluating risvodetinib as a potential disease-modifying therapy for Parkinson's disease (搜索). The partnership centers on SynuSight's 18F-FD4 (搜索) PET tracer, which will be used to visualize and measure alpha-synuclein pathology clearance from the brain in response to treatment.
Under the non-exclusive clinical use license agreement, ABLi Therapeutics (搜索) gains access to 18F-FD4 (搜索) for its Parkinson's disease (搜索) trials, while SynuSight will receive upfront payments and subsequent license-related fees. XingImaging (搜索) will serve as the U.S.-based manufacturer of FD4 and integrate it with their ultra-high resolution NeuroEXPLORER, a next-generation dedicated brain PET imager housed at their newly established imaging facility in New Haven, Connecticut.
Clinical Trial Implementation Strategy
ABLi plans to implement FD4 in two clinical trials scheduled for 2026. The first trial, ABILITY-PD, will re-enroll the 120 participants from the Phase 2a 201 Trial completed in Q4 2024 to conduct a 12-month longitudinal biomarker study measuring the effects of risvodetinib treatment on biomarkers from brain, blood, and tissue. ABILITY-PD will also collect motor, non-motor, and dopamine transporter (搜索)-specific functional data to evaluate how biomarker changes throughout the body correlate with functional outcomes in response to treatment.
The second trial, the c-Abl inhibitor Modification of Parkinson's Disease (搜索) (CAMPD) trial, represents a Phase 2b/3 double-blind, placebo-controlled study that will evaluate risvodetinib's efficacy in up to 500 participants with untreated Parkinson's disease.
Advanced Imaging Technology Integration
The collaboration will leverage FD4's ability to visualize alpha-synuclein (搜索) pathology in the central nervous system to complement ABLi's existing portfolio of blood-borne and tissue biomarkers. This integrated approach aims to establish a comprehensive framework for evaluating risvodetinib's therapeutic effects in Parkinson's disease (搜索).
18F-FD4 (搜索) is a selective, high-affinity PET tracer specifically developed to image pathogenic α-synuclein in Parkinson's disease (搜索) and related α-synucleinopathies. The tracer has demonstrated efficient blood-brain barrier penetration, a clear and stable imaging window with rapid washout, low off-target binding, and favorable safety profiles in both preclinical studies and investigator-initiated trials at Huashan Hospital. In patients with Parkinson's disease and Multiple System Atrophy (搜索), 18F-FD4 has consistently produced high-contrast signals in pathology-relevant brain regions and shown robust disease-differentiation performance.
Therapeutic Target and Disease-Modifying Potential
Risvodetinib (ABLi-148009) is a potent, selective small-molecule inhibitor of the non-receptor c-Abl kinases (搜索), designed for once-daily oral administration. The drug targets the underlying biological mechanisms driving Parkinson's disease (搜索) initiation and progression and is believed to be a disease-modifying therapy that halts disease progression and reverses functional loss arising from Parkinson's disease both inside and outside the brain.
According to the companies, all currently marketed therapeutic approaches for Parkinson's disease (搜索) help manage symptoms, but no available treatments slow or stop the disease's progression. Risvodetinib was recently reported as the first monotherapy shown to improve patient quality of life in a randomized, placebo-controlled clinical trial (NCT05424276) while simultaneously reducing underlying synuclein aggregate pathology in untreated Parkinson's disease. The drug currently has intellectual property protection beyond 2036.
Significant Research Foundation Support
In 2025, 18F-FD4 (搜索) received a $3.84 million research grant from the Michael J. Fox Foundation (搜索) for Parkinson's Research, described as the world's largest nonprofit philanthropy focused on Parkinson's disease (搜索) research. This funding supports the tracer's U.S. clinical registration and development, underscoring the strong scientific rationale and clinical potential of this novel α-synuclein PET tracer. Clinical development is expected to begin in both the U.S. and China in the first quarter of 2026.
Executive Perspectives
"This collaboration represents a key milestone in the global development of FD4. By integrating molecular imaging technologies with rigorously designed clinical trials and longitudinal follow-up, the partnership aims to directly interrogate the disease-modifying potential at the pathological level," said Roger Fan, CEO of SynuSight.
Dr. Milton Werner, Chairman and Chief Executive of ABLi, noted that "ABLi has been expanding its portfolio of disease-related biomarkers, with both blood-borne and tissue measures of alpha-synuclein (搜索) pathology and is excited to add alpha-synuclein PET imaging to this panel to expand our understanding of the potential disease-modifying effect of risvodetinib in PD."
Gilles Tamagnan, CEO of XingImaging (搜索), described the collaboration as "a pivotal opportunity to advance one of the most promising alpha-synuclein (搜索) PET tracers in humans with the potential disease-modifying effect of risvodetinib in PD."