Current reports April 1, 2021<\/p>\n\n\n\n
Legal basis: Article 17 of the Market Abuse Regulation (MAR) \u2013 confidential information.
Date: April 1, 2021 08:33 AM<\/p>\n\n\n\n
With reference to current report No. 13\/2020 of April 29, 2020 on the receipt of approval to commence a Phase I clinical trial of the GPR40 receptor agonist, (hereinafter referred to as CPL’280), the Company hereby informs that on April 1, 2021, it received information from the clinical centre on the completion of the drug administration to volunteers, in the so-called repeated administration, at the highest dosing. The Company hereby confirms the completion of active clinical part of the Phase I study.<\/p>\n\n\n\n
The purpose of the study was to determine the safety and tolerability of the drug, as well as its pharmacokinetic properties after single and repeated administration and interaction with metamorphine and food.<\/p>\n\n\n\n
The entire Phase I study involved 68 healthy volunteers. The drug has demonstrated a favourable safety profile without the observation of any disturbing adverse effects, either after single or repeated administration. Previously, no interactions of CPL’280 have been identified with either metamorphine or food, which provides the comfort of flexible and safe dosing in the chronic management of metabolic diseases.<\/p>\n\n\n\n
Laboratory studies conducted to date among volunteers participating in the Phase I study have not identified any adverse effects of CPL’280 on monitored parameters that may indicate hepatotoxicity, including changes in ALT and AST liver enzyme levels.<\/p>\n\n\n\n
CPL280 represents the latest generation of drugs used in diabetes and metabolic disorders.<\/p>\n\n\n\n
The drug has previously demonstrated an extremely favourable safety profile in preclinical studies, which distinguishes it from other drugs in its class.<\/p>\n\n\n\n
The study was conducted under the GATE project, for which the Company received co-funding from the National Centre for Research and Development (POIR), in the amount of PLN 24.7 million.<\/p>\n","protected":false},"excerpt":{"rendered":"