Lipigon submits CTA for lipid-lowering drug candidate LipisenseThis is an English translation of the Swedish original. In case of discrepancies, the Swedish original shall prevail.
Lipigon Pharmaceuticals AB ("Lipigon"), today announced that the company has submitted an application for a clinical trial (CTA, Clinical Trial Application) to the Swedish Medical Products Agency. The application is for a permit to start a clinical phase I study with the lipid-lowering drug candidate Lipisense. The application to the Swedish Ethical Review Authority will also be submitted shortly. The company is now awaiting information from both authorities before the first subject is recruited for the clinical trial and dosing can start.
The trial aims to document the safety profile of Lipisense and pharmacokinetic properties as well as pharmacodynamic effects via biomarkers.
CEO of Lipigon, Stefan K. Nilsson, comments:
"Following intense work and according to plan, we are now approaching the most important step in Lipigon's history: to start the first-in-human study with Lipisense. There has been a productive and close collaboration between employees and partners, and we are happy that we soon can commence the trial."
The clinical development plan focuses on the protein ANGPTL4 and its unique properties that can give patients with lipid disorders a chance of a new effective treatment. By "turning off" the ANGPTL4 specifically in the liver using the RNA-based drug candidate Lipisense one can also get other valuable effects, such as improved control of blood glucose levels.
CEO Stefan K. Nilsson:
"It is with a great deal of excitement that we look forward to the autumn when we expect that the first and hopefully value-adding results can be communicated."
About Lipisense
The drug candidate is an RNA therapeutics that prevents the cells from producing the disease-promoting target protein ANGPTL4 by destroying the protein-coding RNA before the target protein has been formed. The target gene has a strong genetic association to plasma lipid levels and related diseases, such as type 2 diabetes and cardiovascular disease. For more information, please contact:
Stefan K. Nilsson, CEO, Lipigon
Email: [email protected]
Phone: +46 705 78 17 68
The following documents can be retrieved from beQuoted
Lipigon-submits-CTA-for-lipid-lowering-drug-candidate-Lipise.pdf About Lipigon
Lipigon develops novel therapeutics for patients with lipid metabolism disorders. The company is based on over 50 years of lipid research at Umeå University, Sweden. Lipigon's initial focus is on orphan drugs and niche indications, but in the long term, the company will have the opportunity to target broader indications in the area, such as diabetes and cardiovascular disease. Lipigon's pipeline includes four active projects: the RNA-drug Lipisense for treatment of hypertriglyceridemia; an RNA-drug for treatment of acute respiratory distress syndrome; a gene therapy treatment for the rare disease lipodystrophy, together with Combigene AB (publ); and a small molecule program for the treatment of dyslipidemia in collaboration with HitGen (Inc).
The company's share (LPGO) is traded on the Nasdaq First North Growth Market. Certified Adviser is G&W Fondkommission, email: [email protected], phone: +46 8 503 000 50.
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