Pressmeddelanden och nyheter
Lipigon announces positive results from preparatory preclinical safety study for lipid-lowering drug candidate Lipisense
This is an English translation of the Swedish original. In case of discrepancies, the Swedish original shall prevail.
Lipigon Pharmaceuticals AB ("Lipigon"), a biotech company developing therapeutics for lipid-related diseases, today announced the completion of the first of three preclinical safety studies for the drug candidate Lipisense. The study, which is primarily preparatory for future, longer studies, showed that Lipisense can be given in high doses with no undesirable side effects observed. In addition, the study showed that Lipisense effectively lowered blood triglyceride levels.
Lipisense is a drug candidate for the reduction of elevated lipid levels and a first-in-class treatment with a unique mechanism of action. The candidate is being developed for the treatment of diseases with very high triglyceride levels, which can result in potentially fatal acute pancreatitis (inflammation of the pancreas).
The primary goal of the study was to examine toxicology over the course of two weeks, when giving subcutaneous injections of Lipisense on day one and day eight. The result of the study shows no safety concerns with doses up to 30mg/kg. Furthermore, a dose-dependent decrease of plasma triglyceride levels by 30-50% was observed.
CEO Stefan K. Nilsson comments:
"We are very pleased with the results of this preparatory safety study which shows that the animals tolerated Lipisense well. The fact that we also, somewhat unexpectedly, were able to see efficacy already in this study means that we are entering the next developmental stages with strengthened confidence. It is difficult to predict how the reduction in triglyceride levels may be translated into humans, but the observed reduction of 30-50% is significant. This looks promising as we now approach the planned first-in-human study, where we also expect to see efficacy measurements already in phase I, as previously communicated. The development follows the plan and we confidently look forward to future study results and the clinical trials that are expected to begin during the first half of 2022."
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.
Lipigon will now continue to conduct pre-clinical safety and efficacy studies with Lipisense. Submission of a clinical trial application is estimated to Q1 2022, and the start of the phase I study is estimated to Q2 2022.
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 09:30 am CET, on 10 September 2021.
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 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.