Polish pharmaceutical company Celon Pharma submitted on 24 August to the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL) an application for permission to start Phase I clinical trials on a drug based on the inhibitor of PDE10A – CPL500036. The drug is developed to alleviate psychotic symptoms in humans (especially schizophrenia) and to treat people suffering from Huntington’s disease.
The Company assumes that approximately 60 volunteers will take part in the Phase I study, which will last several months.
In April, the company’s CEO Maciej Wieczorek estimated in an interview with Puls Biznesu that the partnership agreements for the development of CPL500036 could be signed in 2019.
Celon Pharma currently has six drugs in clinical trials or in advanced pre-clinical phase. On August 31, the company was approved by the URPL to launch Phase II clinical trials of an Esketamine-based drug in patients with unipolar depression.