ATLANTA and BOSTON — February 20, 2026 — Leads & Copy — ABLi Therapeutics (“ABLi”), a biotechnology company, has announced the publication of the final trial results from the Phase 2 “201 Trial” (NCT05424276) evaluating risvodetinib in patients with untreated Parkinson’s disease (PD). The results were presented as the “Clinical Breakthrough Lecture” at the 2025 Movement Disorders Society Annual Congress.
According to Dr. Milton Werner, Chairman and Chief Executive of ABLi Therapeutics, Parkinson’s disease affects more than a million people in the U.S. There are currently no approved therapies to slow or halt disease progression. He noted that the inhibition of c-Abl kinases by risvodetinib is becoming recognized as a therapeutic approach that may be able to block pathways of cell death and suppress neuroinflammation in PD.
Werner said the safety and tolerability of risvodetinib over 12 weeks, as well as the reduction in the alpha-synuclein pathology, provide additional confidence that long-term efficacy studies could result in the first disease-modifying therapeutic for PD.
Dr. Christopher Gibbons, Chief Scientific Officer of CND Life Sciences, said they are encouraged by the preliminary data generated using their Syn-One Biomarker Services in ABLi’s 201 Trial for risvodentinib. He noted that multiple natural history studies have shown that phosphorylated alpha-synuclein increases over time, but in the ABLi 201 study there was a dose-dependent decrease in synuclein over 12 weeks.
The publication, entitled, The 201 Trial: a placebo-controlled randomized phase 2 study of safety and tolerance of the c-Abl Kinase Inhibitor risvodetinib in untreated Parkinson’s disease, appears in Nature Aging. The paper highlights the safety and tolerability of risvodetinib, as this was the primary endpoint of the 201 Trial and evaluates the clinical meaning of the first direct measure lowering alpha-synuclein pathology systemically in the human body. The publication can be accessed using DOI: 10.1038/s43587-026-01084-4.
Risvodetinib (ABLi-148009) is a potent, selective small-molecule inhibitor of the non-receptor c-Abl kinases, designed for once-daily oral use that targets the underlying biological mechanisms driving Parkinson’s disease initiation and progression. It is believed to be a disease-modifying therapy that halts disease progression and reverses the functional loss arising from Parkinson’s disease. Risvodetinib was recently shown to improve patient quality of life in a randomized, placebo-controlled clinical trial (NCT NCT05424276) and simultaneously reduced the underlying synuclein aggregate pathology in untreated Parkinson’s disease. Risvodetinib currently has intellectual property protection beyond 2036.
ABLi Therapeutics applies medicinal chemistry and understanding of disease biology to develop small molecule therapeutics that target the cause of diseases that arise from activation or dysfunction of the Abelson Tyrosine Kinases (c-Abl). ABLi utilizes clinically validated data of kinase inhibitors to design and develop novel product candidates with enhanced penetration into the brain, greater potency and target selectivity, and improved safety to treat diseases in which Abl kinase activation or dysfunction is implicated. The Company’s primary focus is on developing therapeutics for the treatment of neurodegenerative diseases like Parkinson’s disease and the Parkinson’s-related neurodegenerative diseases Multiple System Atrophy and Dementia with Lewy Body that are all associated with Abl kinase activation or dysfunction.
Source: ABLi Therapeutics
