On 20 June 2018, Celon Pharma S.A. has submitted an application to the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products for the consent to commence the next stage of the trial, i.e. the clinical phase. A decision in this matter should be issued within 60 days.
The second phase of clinical development will include administering the drug in various doses to patients with unipolar drug-resistant depression, and its aim is to determine the efficacy, pharmacokinetic properties, safety profile of Esketamine in inhalation. It is anticipated that the study will last from 10 to 11 months.
Esketamine in a new pharmaceutical form is developed as an antidepressant, used particularly in drug-resistant depression. As part of all phases of clinical trials, the Company intends to enroll a total of approximately 1,000 patients in three phases of the study. Phase II clinical trial in unipolar drug-resistant depression will be conducted in over a dozen centres across Poland on a group of approximately 90 patients. The drug will be developed in accordance with the medical consultation procedure accepted by the Company in the European Medicines Agency.
The Company’s project obtained PLN 12.7 million of co-funding for the project under the Innovative Economy Operational Programme.