Reference is made to the press release published, in Swedish, by Lipigon Pharmaceuticals on 20 March 2025, 08:15. This press release is a translation in english.
Lipigon Pharmaceuticals AB today announced that its development and commercialisation partner Leaderna Therapeutics has generated positive results from a recently completed Phase I study with Lipisense®. The study was conducted in healthy individuals in China and the results confirm that the drug candidate is safe and well tolerated after single ascending dose (SAD) administration. In parallel, a Phase II clinical trial of Lipisense® in patients with moderately to severely elevated blood lipid levels is ongoing in Sweden.
Lipigon Pharmaceuticals is collaborating with Leaderna Therapeutics Ltd (Leaderna) for the development and commercialisation of Lipisense® in China, Hong Kong, Taiwan and Macau. Leaderna has today informed Lipigon of the results of a recently completed double-blind, randomised, placebo-controlled Phase I clinical trial of Lipisense®. The study aimed to evaluate the tolerability, safety and pharmacokinetic profile of the drug candidate after single and ascending dose (SAD) administration in a total of 24 healthy subjects. These results confirm the safety data from Lipigon's own Phase I clinical trial with Lipisense®, thereby strengthening the evidence for the favourable safety profile of the treatment when administered within the studied dose range.
'We are very pleased to share favourable results from our recently completed Phase I study with Lipisense in healthy subjects. The preliminary study results provide confirmed support for the favourable safety profile of the drug candidate. We look forward to a continued close dialogue with Lipigon for the further clinical development of Lipisense,' said Dr Jinqiao Wan, CEO and co-founder, Leaderna Therapeutics.
Lipigon Pharmaceuticals is currently conducting a Phase II clinical trial in Sweden to evaluate the safety profile of Lipisense® in patients living with moderately to severely elevated blood lipid levels (hypertriglyceridaemia and severe hypertriglyceridaemia, respectively) and thus at increased risk of developing acute pancreatitis. The study will also evaluate any early signals of Lipisense® treatment effect on several biomarkers.
'The positive results from Leaderna Therapeutics' phase I study confirm our own clinical safety data and strengthen our interactions with regulatory authorities for further clinical studies. In addition, the results provide a more solid basis for our dialogues with potential global partners. We look forward to a continued collaboration with Leaderna and to providing new updates on our ongoing development activities as soon as possible', says Johan Liwing, CEO, Lipigon Pharmaceuticals.
For further information, please contact:
Johan Liwing, CEO, Lipigon Pharmaceuticals
Email: johan.liwing@lipigon.se
Phone: +46 (0)70 - 670 36 75
This information is such that Lipigon Pharmaceuticals AB (publ) is required to disclose under the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, on 20 March 2025 at 12.15 CEST.
About Lipigon Pharmaceuticals
Lipigon Pharmaceuticals develops lipid-lowering drugs. The company's most advanced drug candidate, Lipisense®, lowers levels of major blood lipids by eliminating the ANGPTL-4 protein, 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 assess 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 is working to establish a global licensing agreement for Lipisense®. The company's stock (LPGO) is listed on the Nasdaq First North Growth Market. The Certified Adviser is G&W Fondkommission.
