Celon Pharma’s PDE10A inhibitor has reduced involuntary movements in a phase 2 trial of individuals with Parkinson’s disease.
The Polish biotech tested two daily doses of the drug, dubbed CPL’36, in the study of 105 adults with Parkinson’s disease who had levodopa-induced dyskinesia (LID)—a term for involuntary movements caused by long-term use of the widely used Parkinson’s drug levodopa.
By Week 4, the improvement in the Unified Dyskinesia Rating Scale was 12.3 units for patients who received the 20-mg dose and 13.58 units for those who received a 30-mg dose, hitting the trial’s primary endpoint.
The study also hit “most” of its secondary endpoints, including a statistically significant difference in a related dyskinesia rating scale, the company added, without going into more details.
No patients in the 20-mg cohort experienced severe adverse events, compared to 5.7% of the 40-mg group and 8.8% of patients who received placebo. A total of 11.1% of patients in the 20-mg dosing arm discontinued their medication due to treatment-related emergent adverse events, compared to 8.6% of the 40-mg cohort and 2.9% of the placebo group.
“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,” Celon’s CEO Maciej Wieczorek, Ph.D., said in a statement.
“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,” Wieczorek added.
The post-market readout yesterday follows a “statistically significant” benefit demonstrated in a separate phase 2 trial in individuals with schizophrenia last year.
Celon isn’t the only biotech trying to inhibit PDE10, an enzyme expressed in areas of the brain linked to a wide range of diseases that affect cognition. Swiss biotech Noema Pharma's gemlapodect—originally developed by Roche—reduced tic severity in a small phase 2 trial of 15 patients with Tourette syndrome last year. Meanwhile, EuMentis Therapeutics is aiming to take a PDE10A inhibitor into phase 2 in the first quarter of 2025, but it has failed to hit targets for the program in the past.
Joanna Sierzputowska-Prarat, Celon’s main clinical neuropsychiatry lead, said in today’s release 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," Sierzputowska-Prarat added.