Celon Pharma announced positive Phase 2 clinical trial results for its oral, once-daily PDE10A inhibitor, CPL’36, for treating Levodopa-Induced Dyskinesia (LID) in Parkinson’s disease. The study achieved its primary endpoint and several secondary endpoints, demonstrating significant efficacy in reducing LID symptoms. CPL’36 had previously shown promise in Phase 2 trials for schizophrenia.

This development is potentially groundbreaking for Parkinson’s patients experiencing LID, a common and debilitating side effect of standard levodopa therapy. Current treatment options for LID are limited, and CPL’36’s efficacy could significantly improve patients’ quality of life by reducing involuntary movements and improving motor control. The positive results from the schizophrenia trials suggest the drug may have broader applications across neurological conditions, making it a particularly interesting asset for Celon.

In the 4-week, placebo-controlled trial involving 105 adult patients with moderate-severe to severe LID, CPL’36 at doses of 20mg and 40mg showed statistically significant improvements in the Unified Dyskinesia Rating Scale (UDysRS) total score compared to placebo. Specifically, the 20mg dose showed a 12.30 unit improvement (p<0.001, Cohen’s d: 0.90), while the 40mg dose showed a 13.58 unit improvement (p<0.001, Cohen’s d: 1.00). Improvement in the UDysRS objective subscale, a key secondary endpoint, was observed as early as Day 7. The drug was generally well-tolerated, with somnolence being the most common adverse event. Discontinuations due to treatment-related adverse events were higher in the active treatment arms (11.1% for 20mg and 8.6% for 40mg) compared to placebo (2.9%). One serious adverse event of atrial fibrillation was reported in the 40mg group. These positive Phase 2 results position CPL’36 as a potential game-changer in LID management. The next step for Celon Pharma will likely be to initiate larger Phase 3 trials to confirm these findings and further evaluate the drug’s long-term safety and efficacy. Success in Phase 3 could lead to regulatory approval and ultimately provide a much-needed new treatment option for Parkinson’s patients suffering from LID. This could also significantly bolster Celon Pharma’s position in the neurology market.

Source link: https://www.globenewswire.com/news-release/2025/03/04/3036951/0/en/Strong-Proof-of-Concept-Data-from-Phase-2-Trial-of-PDE10A-Inhibitor-CPL-36-a-Novel-Once-Daily-Treatment-of-Levodopa-Induced-Dyskinesia-in-Parkinson-s-Disease.html

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Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.