Celon Pharma submitted an application to the Office for Registration of Medicinal Products along with the documentation of preclinical and clinical trials of phase 1, regarding the initiation of a phase 2 clinical trial in which the CPL’280 compound will be tested in patients with diagnosed type diabetes II, the company said.
The study will be a randomized, double-blind, placebo-controlled trial in a group of approximately 80 patients in which the drug will be administered orally in 4 doses for 2 weeks.
The primary endpoint of the study will be fasting glucose control as assessed by the oral glucose tolerance test (OGTT) after 14 days of CPL’280 treatment. In addition, patients will be assessed for safety, including safety with regard to drug effects. on hepatic parameters, as well as pharmacokinetic evaluation.
The application, together with the prepared documentation, is the end of the extensive first-phase preclinical and early clinical program, in which the drug showed exceptional effectiveness in glycemic control and had a favorable safety profile.
CPL’280 was designed in Celon Pharma laboratories as the latest generation GPR40 agonist, with particular emphasis on safety, especially in terms of the risk of hepatotoxicity (liver damage). In particular, compared to the 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 benefit in diabetic neuropathy, which is the most common long-term complication of type II diabetes. Diabetic neuropathy is another indication for which the company is planning the clinical development of CPL’280.
Phase 2 clinical development of CPL’280 is co-financed by a grant from the National Center for Research and Development under the GATE project.
Celon Pharma is an integrated biopharmaceutical company engaged in research, development, production and sale of pharmaceutical products. It made its debut on the WSE main market in 2016.
Source: ISBnews
