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Press release

Lipigon's development partner Leaderna Therapeutics reports last person treated in ongoing Phase 1 study with Lipisense®

Lipigon Pharmaceuticals

Lipigon Pharmaceuticals AB today announces that the company's development partner Leaderna Pharmaceuticals Ltd has treated the last individual in the ongoing clinical Phase 1 study that aims to evaluate the pharmacological safety and tolerability of the drug candidate Lipisense® in the Chinese population. Concurrently, Lipigon is launching its clinical Phase 2 study with Lipisense® in Sweden.

The Phase 1 study is conducted as part of the company's commercial development agreement with the Chinese American pharmaceutical company Leaderna. Leaderna is a spin-off from the global biotechnology group HitGen Inc. and specializes in the development of advanced RNA therapies targeting metabolic, cardiovascular and inflammatory diseases.

Lipisense® is being developed as a potential treatment for severe hypertriglyceridemia (SHTG) and has previously shown positive results in clinical studies in Europe. The current study aims to investigate the clinical safety and tolerability of Lipisense® further in healthy volunteers. The study includes 24 individuals who have received single ascending dose of Lipisense®, or placebo. The topline data are expected at the end of the first quarter of 2025.

"We are very excited that our commercial partner is making swift advances in the clinical development of Lipisense®. The Phase 1 study is the initial step in the development program that ultimately aims to make our innovative drug candidate available on the Chinese market. We look forward to taking part of the study results and continuing our collaboration with Leaderna in the development of Lipisense®," comments Dr. Stefan K. Nilsson, CEO, Lipigon Pharmaceuticals.

 About Lipisense®

Lipisense® is an investigational drug based on antisense technology, designed to reduce the production of ANGPTL4 protein in the liver. Genetic data show that ANGPTL4 is an independent risk factor for both cardiovascular disease and type 2 diabetes. By blocking the RNA that codes for ANGPTL4, Lipisense® prevents the formation of this disease-promoting protein.

 About Leaderna

Leaderna Therapeutics Ltd. (Leaderna), a spin-off of HitGen Inc. (682222.SH), that focuses on pioneering research and development of synthetic oligonucleotide therapeutics. Leveraging its advanced siRNA design, modification, evaluation, and delivery platform, Leaderna has successfully established a robust pipeline targeting metabolic, cardiovascular, and inflammatory diseases.

For more information, please contact:
Stefan K. Nilsson, CEO, Lipigon
Email: stefan@lipigon.se
Phone: +46 705 78 17 68

About Lipigon

Lipigon Pharmaceuticals AB is a clinical-stage pharmaceutical company developing drugs with new, unique mechanisms of action (first-in-class) for diseases caused by disorders in the body's handling of fats. The company's operations are based on over 50 years of lipid research at Umeå University, Sweden. Lipigon initially focuses on orphan drugs and niche indications, but in the long term, the company has the possibility to target broader indications, such as diabetes and cardiovascular disease. Lipigon's pipeline includes three active projects: the RNA drug Lipisense® targeting elevated triglycerides, with Phase II studies approved in February 2024; an RNA drug for treating lung damage; and a small molecule program for the treatment of dyslipidemia in collaboration with HitGen Inc. Read more at www.lipigon.se.

The company's share (LPGO) is traded on the Nasdaq First North Growth Market. Certified Adviser is G&W Fondkommission.

Attached files

PM-Lipigon-Leaderna-LPO-ENG-2024-09-18.pdf
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