Current report No 26/2021 – submission of an application for consent to commence a phase II trial of CPL’280 in treatment of type 2 diabetes.

Date prepared: 22/06/2021, 15:57

Legal basis: Article 17 section 1 of the Market Abuse Regulation (MAR) – confidential information.

Management Board of Celon Pharma S.A. (the Company) informs that on June 22, 2021 the Company submitted an application to the Polish Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL) along with preclinical and phase-I clinical trial documentation regarding the commencement of a phase II trial, where CPL’280 will be tested in patients with diagnosed type 2 diabetes. The study will be a randomized, double-blind, placebo-controlled clinical trial conducted on a group of approx. 80 patients, with the drug administered orally in 4 doses over the course of 2 weeks.

The main endpoint will be fasting glucose control assessed using oral glucose tolerance tests conducted after 14 days of using CPL’280. Additionally patients will be subject to a therapy safety assessment, including safety of the drug’s impact on the liver function and pharmacokinetic assessment.

The application along with the developed documentation concludes a broad preclinical and early phase-I clinical program, where the drug demonstrated exceptional efficiency in terms of glycemic control and was characterized by a very favorable safety profile. The Company announced the successful finalization of its phase I study in current report No. 21/2020 dated July 23, 2020.

CPL’280 was designed in the Celon Pharma S.A. laboratories as the latest-generation GPR40 agonist, with particular focus on safety, in particular hepatotoxicity. Notably, compared to first-generation GPR40 agonists, CPL’280 does not block bile acid transporters and does not form toxic reactive metabolites. Additionally, in animal models, CPL’280 demonstrated a benefit in terms of diabetic neuropathy, i.e. the most common long-term complication of type 2 diabetes. Diabetic neuropathy is another indication for which the Company is planning the clinical development of CPL’280. 

The phase-2 clinical development of CPL’280 is co-funded by the National Centre for Research and Development under the GATE project grant.