ATLANTA and BOSTON, Feb. 20, 2026 (GLOBE NEWSWIRE) -- ABLi Therapeutics (“ABLi”), a biotechnology company developing therapeutics to address diseases that arise from activation of Abelson Tyrosine Kinases (c-Abl kinases), announces publication of the final trial results from the Phase 2 “201 Trial” (NCT05424276) evaluating risvodetinib in patients with untreated Parkinson’s disease (PD). These results were presented as the “Clinical Breakthrough Lecture” during the keynote session at the 2025 Movement Disorders Society Annual Congress.
“Parkinson’s disease remains one of the most prevalent neurodegenerative diseases worldwide, affecting more than a million people in the U.S. alone. To date, there are no approved therapies to slow or halt disease progression. Inhibition of the c-Abl kinases by risvodetinib is becoming recognized as the first therapeutic approach that may be able to both block pathways of cell death and suppress neuroinflammation, the two hallmarks of neurodegeneration in PD,” noted Dr. Milton Werner Chairman and Chief Executive of ABLi Therapeutics. “The outstanding safety and tolerability of risvodetinib over 12-weeks and the reduction in the alpha-synuclein pathology linked to the cause of disease provide additional confidence that long-term efficacy studies could result in the first disease-modifying therapeutic for PD.”
"We are very encouraged by the preliminary data generated using our Syn-One Biomarker Services in ABLi’s 201 Trial for risvodentinib,” said Christopher Gibbons, MD, Chief Scientific Officer of CND Life Sciences. “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, a leading journal publishing transformative outcomes in aging pre-clinical and clinical research, can be accessed HERE or using DOI: 10.1038/s43587-026-01084-4. 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.
About Risvodetinib (ABLi-148009)
Risvodetinib 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. Risvodetinib is believed to be a disease-modifying therapy that halts disease progression and reverses the functional loss arising from Parkinson’s disease inside and outside of the brain. All marketed therapeutic approaches to treat Parkinson’s help manage the symptoms of the disease, but there are currently no available treatments to slow or stop the disease’s relentless progression. Recently, risvodetinib was the first monotherapy 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.
About ABLi Therapeutics
ABLi Therapeutics (“ABLi”) applies innovative medicinal chemistry and a deep 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). Leveraging its expertise in drug design, 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. For more information visit www.ablitherapeutics.com or follow us on LinkedIn, Facebook or Instagram.
Contacts:
For ABLi Therapeutics
info@ablitherapeutics.com
Investor/Media
Mike Moyer
Managing Director – LifeSci Advisors
mmoyer@lifesciadvisors.com
