Lipigon Pharmaceuticals AB (publ) today announced that the last patient in the company's Phase II clinical study of Lipisense® has completed the three-month follow-up. The study includes a total of 23 patients who are monitored for six months after the final treatment visit and aims to evaluate the treatment safety and tolerability of Lipisense®. The company also intends to assess early signals of the drug candidate's treatment effect. Preliminary study data on treatment safety and efficacy based on results from the three-month follow-up are expected to be presented before the end of 2025.
Lipisense® is an RNA drug candidate with the potential to enhance the body's breakdown of blood lipids and counteract severe diseases such as acute pancreatitis and cardiovascular disease. The primary objective of the ongoing Phase II clinical study is to evaluate treatment safety and tolerability in patients with moderately to severely elevated blood lipid levels - hypertriglyceridemia and severe hypertriglyceridemia, respectively. The study will also assess early signals of treatment effects on the blood lipid markers triglycerides and remnant cholesterol, as well as insulin sensitivity.
The study design includes four treatment sessions - one per week over a total of one month - followed by a three-month post-treatment follow-up and a long-term follow-up six months after the last treatment. At the three-month follow-up, it is possible to assess both treatment safety and potential efficacy. The company is now entering an analysis phase of study data from all patients' three-month follow-ups. A preliminary analysis of the study's data (top-line data) is expected to be presented before the end of 2025. Full study data are expected during the first half of 2026.
"We are entering an exciting time for both Lipigon and Lipisense®. During the autumn, we have worked intensively to position our drug candidate for the next phase of business development. The preliminary results from our Phase II study will be crucial for our continued strategy, and we see several possible paths forward depending on the outcome," says Johan Liwing, CEO of Lipigon Pharmaceuticals.
For further information, please contact:
Johan Liwing, Chief Executive Officer, Lipigon Pharmaceuticals
Email: johan.liwing@lipigon.se
Phone: +46 (0)70 670 36 75
About Lipigon Pharmaceuticals
Lipigon Pharmaceuticals develops lipid-lowering drugs. The company's most advanced drug candidate, Lipisense®, reduces the levels of major blood lipids by removing the protein ANGPTL-4, which otherwise inhibits the breakdown of blood lipids. Lipisense® is currently being evaluated in a Phase II clinical study in patients with elevated blood lipids. In addition to safety and tolerability, the study aims to evaluate Lipisense®'s effect on triglyceride and cholesterol levels - two blood lipids that, at elevated levels, can lead to serious cardiovascular diseases. Lipisense® is being developed in collaboration with Leaderna Therapeutics, which holds the rights to the Chinese market. Lipigon aims to establish a global licensing agreement for Lipisense®. The company's share (LPGO) is listed on Nasdaq First North Growth Market. Certified Adviser: G&W Fondkommission.