A New Hope: Groundbreaking Trial Aims to Stop Parkinson's Before It Starts

ATLANTA, GA – January 27, 2026 – In a move that could fundamentally reshape the fight against Parkinson's disease, ABLi Therapeutics announced today it will partner with The Michael J. Fox Foundation for Parkinson’s Research (MJFF) to test a promising drug in individuals who show the earliest biological signs of the disease, even before a clinical diagnosis can be made.

The collaboration will see ABLi’s lead drug candidate, risvodetinib, included in the MJFF-sponsored Path to Prevention (P2P) platform trial. This ambitious study represents a major strategic shift in neurology, moving away from merely treating the symptoms of Parkinson's to attempting to halt its progression in the earliest, pre-symptomatic stages.

For decades, a diagnosis of Parkinson's disease has meant an inevitable, relentless decline. Current treatments primarily focus on replacing dopamine to manage motor symptoms like tremors and stiffness, but no therapy on the market can slow or stop the underlying neurodegenerative process. This new trial aims to change that narrative entirely by intervening at the dawn of the disease.

A New Frontier: Targeting Prodromal Parkinson's

The Path to Prevention trial will focus on a unique group of participants: those with what is known as “prodromal Parkinson’s disease.” These are individuals who do not have a formal diagnosis and may not yet experience the debilitating motor symptoms typically associated with the condition. However, they carry the key biological hallmarks that signal the disease process has already begun.

The P2P trial will leverage the infrastructure and deep data reserves of the Parkinson’s Progression Marker Initiative (PPMI), a landmark study launched by MJFF in 2010. Participants eligible for P2P will be drawn from the PPMI population and must exhibit specific biomarkers: the presence of pathological alpha-synuclein protein, as measured by the highly sensitive Seed Amplification Assay (SAA), and evidence of dopamine system dysfunction, confirmed by DAT-SPECT imaging. Many of these individuals may also have early non-motor symptoms like REM sleep behavior disorder or a reduced sense of smell.

By targeting this population, researchers hope to test therapies when the window for intervention is greatest, before widespread and irreversible neuronal damage has occurred. The P2P trial is structured as a Phase 2, randomized, double-blind, placebo-controlled platform trial. This innovative design allows multiple investigational therapies from different companies to be tested simultaneously against a shared placebo group, dramatically increasing the efficiency and speed of drug development.

The trial's primary endpoints are designed to provide definitive evidence of disease modification. Researchers will measure the rate of change in both dopamine transporter imaging and clinical motor scores (using the MDS-UPDRS scale) over a period of two to three years. The ultimate goal is to determine if a therapy like risvodetinib can prevent or significantly delay the progression to a formal Parkinson's diagnosis.

The Science of a Disease-Modifying Candidate

At the heart of this new trial is risvodetinib, a potent, selective small-molecule inhibitor of c-Abl kinases. Developed by ABLi Therapeutics, this once-daily oral pill is not another dopamine-based therapy. Instead, it is designed to target the underlying biological mechanisms believed to drive the initiation and progression of Parkinson's disease.

The central culprit in Parkinson's pathology is the misfolding and aggregation of a protein called alpha-synuclein. These toxic clumps are thought to spread from neuron to neuron, causing the cell death that leads to the disease's devastating symptoms. The c-Abl kinase has been identified as a key player that promotes this pathological process. By inhibiting c-Abl, risvodetinib is believed to halt the progression of alpha-synuclein pathology, offering the potential to be a truly disease-modifying therapy.

This hypothesis is supported by promising earlier data. “Following the successful completion of the Phase 2 201 Trial that assessed the safety, tolerability and disease-modifying potential of risvodetinib in participants with early untreated PD, we are excited to be the first of several companies to enter into a collaboration agreement to join the Foundation’s P2P trial,” said Dr. Milton Werner, Chairman and CEO of ABLi. “We believe risvodetinib may be disease-modifying based on synuclein biomarker data. We’re excited to have the opportunity to evaluate the effect of risvodetinib even earlier in the disease course through P2P.”

A Dual Strategy and the Road Ahead

The inclusion of risvodetinib in the P2P trial is part of a comprehensive, two-pronged strategy by ABLi Therapeutics. The company is simultaneously advancing a separate pivotal registration trial, known as CAMPD (C-Abl inhibitor Modification of Parkinson’s Disease), for patients who have already been diagnosed with early, untreated Parkinson's disease.

“We believe that risvodetinib is a unique investigational therapy with the potential to alter the course of disease for millions of patients with PD,” stated Christopher Meyer, ABLi’s Chief Operating Officer. “P2P will run alongside our registration trial... The primary endpoint for CAMPD is intended to directly measure the ability of risvodetinib to delay disease progression in hundreds of patients within three years of a Parkinson’s diagnosis.”

This dual approach—targeting both prevention in the prodromal stage with P2P and treatment in the early clinical stage with CAMPD—positions ABLi and its lead candidate at the forefront of Parkinson's research. The collaboration with The Michael J. Fox Foundation, a globally recognized leader in accelerating innovative research, provides significant validation and strategic support for this endeavor.

The P2P trial is expected to launch in the coming months, with ABLi being the first of what is expected to be several industry partners. This collaborative model, championed by MJFF, is seen as essential for tackling a disease as complex as Parkinson's. While the path to a proven preventative therapy is long and fraught with the challenges inherent in clinical research, the launch of the Path to Prevention trial marks a decisive and hopeful shift in the battle against this neurodegenerative disease, moving the focus from managing symptoms to pursuing a future free from its progression.