Date prepared: 22\/06\/2021, 15:57<\/p>\n\n\n\n
Legal basis: Article 17 section 1 of the Market Abuse Regulation (MAR) \u2013 confidential information.<\/p>\n\n\n\n
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\u2019280 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.<\/p>\n\n\n\n
The main endpoint will be fasting glucose control assessed using oral glucose tolerance tests conducted after 14 days of using CPL\u2019280. Additionally patients will be subject to a therapy safety assessment, including safety of the drug\u2019s impact on the liver function and pharmacokinetic assessment.<\/p>\n\n\n\n
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.<\/p>\n\n\n\n
CPL\u2019280 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\u2019280 does not block bile acid transporters and does not form toxic reactive metabolites. Additionally, in animal models, CPL\u2019280 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\u2019280. <\/p>\n\n\n\n
The phase-2 clinical development of CPL\u2019280 is co-funded by the National Centre for Research and Development under the GATE project grant.<\/p>\n","protected":false},"excerpt":{"rendered":"
Submission of an application for consent to commence a phase II trial of CPL\u2019280 in treatment of type 2 diabetes.<\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[25],"tags":[],"class_list":["post-21434","post","type-post","status-publish","format-standard","hentry","category-current-report"],"acf":[],"yoast_head":"\n