Current report 27/2021 – Status update of the phase II clinical trial on an esketamine-based drug in patients with bipolar depression

Date: 06/23/2021, 5:40 pm
Legal basis: Article 17 of the Market Abuse Regulation (MAR) – confidential information.

In connection with current report 1/2021 on positive results of the phase II clinical trial on Celon Pharma's DPI esketamine in bipolar treatment-resistant depression dated January 8, 2021, the Company hereby informs that on June 23, 2021, the organization tasked with organizing and monitoring of the trial provided the Company's Management Board with an update on the course and results of the trial, taking into account the 6-week follow-up.

As at June 23, 2021, full data have been entered into the database, including the 6-week follow-up of 81 patients, which constitutes 92% of patients enrolled into the trial.

Data from day 14 for the primary endpoint have been verified for 100% of patients. The data, including the 6-week follow-up, have been verified in full for 39 patients, which constitutes 44% of patients participating in the study. 

The bipolar depression phase II study was participated by 88 of patients diagnosed with bipolar treatment-resistant depression, which was defined as at least two mood-stabilizing treatment strategies with marketing authorizations or with proven efficacy in treatment of bipolar depression.

The drug was administered in three doses: 24 mg (N=23), 36mg (N=21) and 48mg (N=22), obtained by way of an increasing number of active inhalations. The drug was administered 4 times (twice a week) on days 1, 4, 8 and 11. Placebo was administered to 22 patients. The main efficacy scale adopted for the trial was the Montgomery Asberg Depression Rating Scale (MADRS). As at January 8, 2021, assessments were conducted for the primary endpoint (PEP) on day 14 (change in the MADRS score) and some of the other endpoints, as well as partial safety and tolerability results, including the CADSS score over the 2-week drug administration period. Results for day 14 were published in current report 1/2021 on January 8, 2021.

On June 23, 2021 the Company was informed that results for day 14 have not changed, confirm the drug’s statistically significant efficacy and will constitute the basis for the drug’s basic assessment in terms of the offered clinical benefit.

As at June 23, 2021 the Company assessed the long-term effect of the response and remission obtained in the active treatment phase. The assessment covered data available as at June 23, 2021; in line with the above-listed information, some of the data is still subject to verification by clinical monitors.

The clinical response obtained in the active treatment phase (day 14) was continued over the course of subsequent 6 weeks in 11 of 11 patients in the Esk 24mg arm, in 9 of 11 patients in the Esk 36mg arm and in 15 of 15 patients in the Esk 48mg arm vs continued response in 3 of 5 patients in the placebo arm.

Remission obtained in the active treatment phase (day 14) was continued over the course of subsequent 6 weeks in 9 of 10 patients in the Esk 24mg arm, 7 of 9 patients in the Esk 36mg arm and in 9 of 10 patients in the Esk 48mg arm vs continued response in 1 of 2 patients in the placebo arm.

No serious adverse effects, deaths or suicide attempts have been reported in the study. Treatment discontinuation by day 14 have been reported in 3 patients in the placebo arm and 1 patient in the Esk24 arm. No treatment discontinuations have been reported in the Esk36 and Esk48 arms.

In the opinion of the Company's Management Board, the current data confirm the drug’s high efficacy, including its long-term effect, good tolerability and constitute a strong basis for continuing development in phase-III clinical research. Details of the trial will be published and presented at upcoming medical conferences.

Based on information received from the organization tasked with its organizing and monitoring, the Management Board confirms that delays in the clinical trial monitoring processes were caused by difficulties in access to source data in study sites resulting from the COVID-19 pandemic in Q1 and Q2 of 2021.