New Parkinson’s Medication Moves Closer to Phase 3 Testing

A potential new treatment for untreated Parkinson’s disease—called Risvodetinib—is one step closer to advanced clinical testing. Developer Abli Therapeutics recently met with the U.S. Food and Drug Administration (FDA) to prepare for a Phase 3 trial, which is a critical step before applying for approval to make the drug available. 🧠 How Does Risvodetinib Work? Risvodetinib (formerly IkT-148009) is an oral medication designed to block an enzyme called c-Abl kinase. Research suggests that this enzyme may become too active in people with Parkinson’s and contribute to nerve cell damage. By blocking c-Abl, Risvodetinib aims to: 🛡️ Protect dopamine-producing nerve cells in the brain 🧠 Slow or stop disease progression 🚶 Improve motor symptoms like bradykinesia (slowness of movement) 🔬 What Happened in the Phase 2 Study? In a recent Phase 2 trial (NCT05424276), people with early Parkinson’s were given a daily capsule of Risvodetinib (50, 100, or 200 mg) or a placebo for 12 weeks. ✅ Results showed: Improved scores on the MDS-UPDRS, a scale that measures Parkinson’s symptoms Better outcomes on the Schwab and England scale, which tracks daily living abilities These improvements suggest the medication may help with everyday functioning and independence. 📋 What’s Next for Phase 3? The FDA supported several key plans for the next stage: ✅ Use MDS-UPDRS Part 2 (daily living activities) as the main goal of the Phase 3 trial, reflecting real-world impact ⏳ Include a new secondary goal: measuring how long it takes before someone needs levodopa/carbidopa—a common treatment. Delaying this could mean the medication is helping slow the disease. 👁️ Reduce the number of required vision checks, as no eye problems have been linked to the medication so far 🧪 Encourage further study of biomarkers in skin and fluids to help track how people respond to treatment 📌 Why This Matters For people living with Parkinson’s new treatment options that might protect brain cells and slow progression are greatly needed. While current therapies help with symptoms, they don’t yet stop the disease from advancing. Risvodetinib offers a hopeful step forward, and Phase 3 trials will be crucial in learning if it can truly make a lasting difference.