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Lipigon receives CTA approval for lipid-lowering candidate Lipisense

Lipigon Pharmaceuticals AB ("Lipigon") today announced that the company has received approval from the Swedish Medical Products Agency to start a clinical phase I study with the lipid-lowering drug candidate Lipisense.

The trial aims to document the safety profile of Lipisense and pharmacokinetic properties as well as pharmacodynamic effects via biomarkers.

"Lipigon is now officially a clinical-stage pharmaceutical company. It is of course a major milestone for us founders and the whole Lipisense team. I am extremely proud of everyone's dedication and hard work which has meant that we have kept our ambitious timelines throughout the project," says Stefan K. Nilsson, CEO of Lipigon.

The clinical development plan focuses on the protein ANGPTL4 and its unique properties that can give patients with lipid disorders a chance to 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.

"We know that, in addition to monitoring the usual safety parameters, we will also have a very good chance of studying efficacy in terms of triglyceride reduction within the first six months of the clinical phase I study. We are confident that we are working with the best target protein, that we are first-in-class, and that there is a solid interest in our field, so now we are rolling up our sleeves for round two-the clinical development phase," says Stefan K. Nilsson. 

About Lipisense

The drug candidate is an RNA therapeutic 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 with 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: stefan@lipigon.se
Phone: +46 705 78 17 68

This is information that Lipigon Pharmaceuticals AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out above, at 07:00 PM CET, on 27 April 2022.

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: ca@gwkapital.se, phone: +46 8 503 000 50.