- Statistically significant improvement in primary endpoint (UDysRS total scale) at Week 4 and positive benefit in the key secondary endpoint (UDysRS objective subscale), beginning at Day 7
- Favorable tolerability profile demonstrated in both active treatment arms
- Building on the positive Phase 2 results previously reported in Schizophrenia in 2024
WARSAW, Poland, March 04, 2025 (GLOBE NEWSWIRE) -- Celon Pharma S.A. (CLN.WA) today announces robust and positive Phase 2 clinical trial results for its PDE10A inhibitor (CPL’36), a novel, oral, once-daily medication for the treatment of Levodopa-Induced Dyskinesia (LID) in Parkinson’s disease. The study met its primary endpoint and many of its secondary endpoints. CPL’36 demonstrated robust and consistent efficacy across all utilized scales measuring improvement in treatment of LID in Parkinson’s disease. The effect size was large and clinically meaningful. CPL’36 was previously investigated as a potential treatment for schizophrenia and demonstrated positive Phase 2 results that were reported in July 2024.
“I am very pleased that the clinical effect of CPL'36 has now been confirmed also for the treatment of LID dyskinesia in Parkinson’s disease. The results are unequivocally positive, clinically meaningful, and statistically significant, and have met all the criteria we prespecified. We believe that CPL’36 has potential to significantly contribute to the expansion and advancement of the global market for Parkinson’s disease pharmacotherapy, and to provide sizeable clinical benefits to LID patients who are underserved by current treatments.”- stated Maciej Wieczorek, Ph.D., CEO of Celon Pharma S.A.
“It is important to note that CPL’36 has a unique pharmacodynamic profile, characterized by rapid enzyme dissociation, which distinguishes it from other PDE10A inhibitors. We believe this attribute is key to the positive clinical outcomes we have generated thus far,” said Joanna Sierzputowska-Prarat, Main Clinical Neuropsychiatry Lead at Celon Pharma S.A.
Trial description
The CPL’36 Phase 2 study was multinational, multicenter, randomized, placebo-controlled trial conducted in a group 105 adult patients with LID dyskinesia in Parkinson’s disease. CPL’36 was administered orally in one of two doses of 20 mg or 40 mg, once daily and placebo controlled at a ratio (1:1:1) for a period of 4 weeks. Patient baseline severity was moderate-severe to severe, as characterized by a UDysRS (Unified Dyskinesia Rating Scale) total score of approximately 45.
At Week 4, the improvement in UDysRS total score (primary endpoint) for the 20 mg dose was 12.30 units (LS Mean difference from placebo, p<0.001, Cohen’s d: 0.90) and improvement for the 40 mg dose was 13.58 units (LS Mean difference from placebo, p<0.001, Cohen’s d: 1.00).
CPL’36 treatment was associated with improvement in most secondary endpoints, including the UDysRS objective subscale, in which the improvement in both active groups was statistically significant from Day 7 of the treatment phase.
Drug tolerability was favorable with most severe adverse events occurring in the placebo-treated patients (8.8% in placebo group, 0% in 20 mg dose and 5.7% in 40 mg dose). Treatment related emergent adverse events leading to discontinuation of study medication were recorded in 2.9% of the placebo group, 11.1% of the 20 mg dosing arm, and 8.6% in the 40 mg dosing arm. The most common adverse event reported in both active groups was somnolence with mild to moderate intensity.
No deaths were reported in the trial, and one Serious Adverse Event of atrial fibrillation with moderate intensity was reported in the 40 mg dosing arm.
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ABOUT CELON PHARMA
Celon Pharma is an integrated biopharmaceutical company which designs, develops, manufactures and distributes pharmaceutical products. It was founded in 2002 by Maciej Wieczorek, PhD. The Company currently has approx. 500 employees. It employs approx. 160 scientists responsible for research and development, half of whom either have a PhD or are in the process of acquiring their PhD. The Company’s pipeline includes more than a dozen projects for the development of innovative drugs with therapeutic groups such as oncology, neuro-psychiatry, autoimmunity and metabolism. The Company has its own research and development laboratories, which allow it to develop its own pharmaceutical technologies by using extensive laboratory equipment resources, as well as the experience and expertise of its staff. It also has a modern manufacturing facility where dry pharmaceutical forms are manufactured. Over the last few years, the Company has introduced products into the market in the following therapeutic areas: oncology, central nervous system diseases, cardiology, respiratory diseases. The Company has been developing the technology for manufacturing inhalation drugs and several projects of innovative drugs since 2007. It has been listed on the Warsaw Stock Exchange since 2016. www.celonpharma.com
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