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CORRECTION: In previous press release, the time stamp in the MAR label was incorrect. Corrected pressrelease follows below.
"Lipigon announces positive top-line data from phase I clinical study of Lipisense"
Lipigon Pharmaceuticals AB ("Lipigon") today announced positive top-line results from a phase I SAD study of its investigational medicine Lipisense in healthy volunteers.
Lipisense is an RNA drug candidate developed to lower blood lipid triglycerides in patients with severely elevated levels by preventing the production of the protein ANGPTL4.
Lipigon reports that the phase I SAD (Single Ascending Dose) study demonstrated that Lipisense has a favorable safety and pharmacokinetic profile. Lipisense was well tolerated, with no serious adverse events reported.
The SAD part included 20 healthy study participants, and the primary goal was to evaluate safety and tolerability after an injection of Lipisense at three different dose levels or placebo.
Since no serious adverse effects were reported, the company has also decided to add a fifth cohort of healthy subjects at a 72 mg dose in the SAD study.
"We are happy to have reached another critical milestone in the Lipisense development. Our candidate drug is well tolerated and not causing adverse effects. Thus, we can start the MAD part of our phase I study. Thanks to this clean safety profile, we have also decided to add a higher dose group. These results mean a substantial de-risking for the future clinical development plan," says CEO Stefan K. Nilsson.
"Our development plan leaves as little time as possible between studies, and we are already in preparation for phase II clinical studies. It is not unlikely that we will be able to start the phase II study next year," says Stefan K. Nilsson.
Lipisense is an investigational antisense medicine designed to reduce the production of ANGPTL4 in the liver. ANGPTL4 has a strong genetic association with plasma lipid levels and related diseases such as cardiovascular disease and type 2 diabetes.
For more information, please contact:
Stefan K. Nilsson, CEO, Lipigon
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 12:17 PM CET, on 5 October 2022.
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.