Current report No. 25/2023- Information concerning preliminary results of the phase 2a clinical trial on CPL’280 in treatment of type 2 diabetes

Subject: Information concerning preliminary results of the phase 2a clinical trial on CPL’280 in treatment of type 2 diabetes
Legal basis: Article 17 section 1 of the Market Abuse Regulation (MAR) – inside information.
Date: 27.12.2023, 17:19

Content of the report:

In relation to current report no. 3/2022 of January 21, 2022 concerning the commencement of a phase 2 clinical trial on CPL’280 in treatment of type 2 diabetes, the Management Board of Celon Pharma S.A. (the “Company”) hereby announces the preliminary results of this trial.

It was a phase 2a trial aimed at assessing the efficacy, safety, tolerability and pharmacokinetics of 4 different doses of CPL’280 in patients diagnosed with type 2 diabetes administered orally (once daily) for a period of 14 days. CPL’280 was administered in the following doses: 60 mg, 120 mg, 240 mg and 480 mg, in a group of 80 patients. Additionally, the trial involved a control group – patients receiving placebo. The trial participants were receiving either the study compound or placebo, as add-on to treatment as usual, i.e., usually metformin.

The primary endpoint was assessing efficacy on the basis of the change of glucose levels on day 14 in comparison to day 0, expressed as AUC (Area Under the Curve) in a 3-hour oral glucose tolerance test (OGTT). The remaining efficacy endpoints concerned changes for other glycemic and metabolic parameters. Safety endpoints concerned the frequency and type of adverse effects.

CPL’280, the study compound, reduced the AUC in OGTT in the range (LS mean) of 31.42-65.22 mg/dL*h. These changes were numerically greater than the changes in the placebo group (change of 59.31 mg/dL*h) for 60 mg (change of 60.98 mg/dL*h), for 120 mg (change of 64.60 mg/dL*h), for 480 mg (change of 65.22 mg/dL*h), however the change did not reach statistical significance for any of the studied doses, resulting in failure to meet the primary endpoint in terms of efficacy.-

The 480 mg dose compared to other doses has demonstrated the highest benefit numerically in many other efficacy endpoints.

The studied CPL’280 is characterized by high tolerability. No severe adverse effects have been identified during the trial, and the frequency of reported adverse effects during the trial for the doses of: 60 mg, 120 mg, 240 mg, 480 mg was 46.7%, 41.2%, 40%, 33.3%, respectively, and 41.2 in the case of placebo. The trial has also shown no evident signals of hepatotoxicity.

The Company is analyzing the subsequent data from the trial and on that basis will soon make decisions regarding whether the development of CPL’280 in the indication of type 2 diabetes should be continued.

CPL’280 is a second generation GPR40 receptor agonist. This compound has been designed with the consideration of minimizing the risk of hepatotoxicity typical for the administration of first generation GPR40 agonists. CPL’280 is additionally being developed in diabetic neuropathy; in this indication it demonstrated a strong analgesic effect in numerous preclinical models.