While current treatments for Parkinson’s disease can alleviate symptoms, they often fail to address the underlying cause or halt disease progression. However, new findings from the 201 Trial have shown positive safety and tolerability for a small molecule medication called risvodetnib. Read more about the expected data to be presented at the 2024 American Academy of Neurology Annual Meeting.
Parkinson's disease (PD) is a progressive neurodegenerative disorder that affects movement and develops in patients gradually over time. While current treatments alleviate symptoms, they often fail to address the underlying cause or halt disease progression. In the quest for more effective therapies, recent clinical trial findings on risvodetinib show potential for slowing disease progression.
Risvodetinib is an experimental therapy developed by Inhibikase Therapeutics. It’s a small-molecule medication designed to block Abelson tyrosine kinase (c-Abl), which is a protein that plays a role in the development of neural tissue. By blocking c-Abl, risvodetinib aims to reverse the loss of dopamine-producing neurons, which is a key feature of PD, and could potentially slow or halt disease progression.
The current status of risvodetinib clinical trials for PD involves an ongoing Phase 2 trial, known as the 201 Trial (NCT05424276) and aims to evaluate the efficacy and safety of risvodetinib in untreated adult patients with PD. The study is testing risvodetinib at doses of 50, 100, and 200 milligrams per day against a placebo. Over a period of 12 weeks, 120 patients were randomly assigned in a 1:1:1:1 ratio and subsequently rolled into a 12-month extension study with the placebo group given the top therapeutic dose. To measure safety and efficacy, researchers evaluated the frequency and severity of adverse events, cardiovascular safety, standard laboratory analyses, and changes in vision. A set of 15 secondary endpoints were established to explore the potential therapeutic benefits of both motor and non-motor functions within the Central and Enteric Nervous Systems. To further enrich the understanding of the treatment's effects, biomarker analysis using cerebrospinal fluid and plasma assessment via seed-amplification assay, along with skin biopsy, were integrated to complement the functional assessments.
The next updates of the 201 Trial will be presented at the 2024 American Academy of Neurology Annual Meeting in a poster session on Wednesday, April 14. This will provide a first look at whether risvodetinib can be a potential therapeutic option for Parkinson’s disease.
References
Clinical trials. Inhibikase Therapeutics, Inc. https://www.inhibikase.com/patient-resources
Inhibikase Therapeutics, Inc. - the 201 trial. Inhibikase Therapeutics, Inc - The 201 Trial. https://www.the201trial.com
Lobo A. Risvodetinib may slow parkinson’s progression, clinical trial... Parkinson’s News Today. March 2024. https://parkinsonsnewstoday.com/news/risvodetinib-slow-progression-parkinsons-clinical-trial/
Margarida Maia P. High-dose risvodetinib effective, safe in parkinson’s, New Data Show. Parkinson’s News Today. October 2023. https://parkinsonsnewstoday.com/news/high-dose-risvodetinib-safe-effective-per-unblinded-data-trial/
Marisa Wexler M. Parkinson’s therapy risvodetinib shows good safety profile in trial. Parkinson’s News Today. February 2024. https://parkinsonsnewstoday.com/news/good-safety-profile-seen-parkinsons-therapy-risvodetinib-trial/
Werner MH, Olanow CW, McGarry AJ, et al. The 201 Trial in Untreated Parkinson’s Disease. Abstract details. Abstract Details (aan.com)
Werner MH;OlanowCW;McGarryA;MeyerC;KrugerS;KlintC;PellecchiaJ;WalakerS;EreshefskyL;BlobL;HassmanH;RodriguezC;SamaraE;SafirsteinB;Ellenbogen A; A phase I, randomized, sad, mad, and PK study of risvodetinib in older adults and parkinson’s disease. Journal of Parkinson’s disease.https://pubmed.ncbi.nlm.nih.gov/38251063/
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