Lipigon Pharmaceuticals AB (Lipigon) announced that the company has submitted an application for a Phase II clinical trial for its blood lipid-lowering drug candidate, Lipisense®?. The application has been submitted via CTIS (Clinical Trial Information System), which means that a joint application for approval is sent to the Swedish Medical Products Agency (Lakemedelsverket) and the Swedish Ethical Review Authority (Etikprovningsmyndigheten) through the electronic EU portal, CTIS. Lipigon is now awaiting the response from the authorities before recruiting the first patient for the study.

Typically, the approval process takes 60-106 days under normal circumstances. The purpose of the study is to document the safety profile of Lipisense®? in patients with severe hypertriglyceridemia (sHTG) and type 2 diabetes.

Additionally, secondary and exploratory objectives include the investigation of various biomarkers, such as blood lipid levels and insulin sensitivity. The Phase II study is conducted in collaboration with the contract research organization Link Biomedical at three trial sites in Sweden: Karolinska University Hospital Huddinge, Vasteras Hospital, and the Clinical Trial Consultants (CTC) trial unit in Uppsala. The clinical development plan focuses on the protein ANGPTL4 and its unique properties that can provide patients with lipid disorders with the potential for a new and effective treatment.

"Switching off" the production of the ANGPTL4 protein, specifically in the liver, using the RNA-based drug candidate Lipisense®? may also have other valuable effects, such as improved control of blood glucose levels.