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Lipigon announces further positive data from phase I trial of Lipisense
Lipigon Pharmaceuticals AB ("Lipigon") today announced positive safety results from multiple dosing in the phase I trial with the drug candidate Lipisense. The drug candidate is being developed for treating hypertriglyceridemia.
Lipisense is a drug candidate developed to lower blood lipid triglycerides in patients with severely elevated levels by preventing the production of the protein ANGPTL4 in the liver.
Phase I trials started in May 2022, and today, Lipigon announced additional safety results from multiple dosing showing a good safety profile for the drug candidate Lipisense in the ongoing trial. The current safety data includes the completed 6 and 12 mg multiple ascending doses (MAD) cohorts. Based on the recommendation from the safety committee, Lipigon decided to progress with a 36 mg MAD cohort. Altogether four groups with 32 persons can be studied in the MAD cohorts.
In the single ascending dose (SAD) groups, and as reported previously, the investigational drug also demonstrates a favorable safety profile. In a previous press release, Lipigon announced positive safety results for a 36 mg dosage in the SAD part. Now, the company can report similar safety results for a dosage of 72 mg. Since no serious adverse effects and only mild reversible adverse effects related to treatment were reported, the company has also decided to include a 144 mg dose group in the SAD study. This group will be tested and analyzed in parallel with the remaining groups of the MAD study.
"We are pleased to have a good safety profile from both the SAD and the MAD cohorts. This is a major milestone in developing our drug candidate Lipisense. With the good data received so far, we are currently exploring options to finish phase I earlier than expected without doing the final MAD cohort. This would allow us to progress with the start of phase II clinical trials. Here, we will study Lipisense in the most relevant patient cohorts, which is very attractive from a value-creating perspective," says CEO Stefan K. Nilsson.
About Lipisense
The drug candidate is an RNA therapeutics that prevents the cells from producing the disease-promoting target protein ANGPTL4 in the liver by destroying the protein-coding RNA before the target protein has been formed. Genetic data shows that ANGPTL4 is an independent risk factor for both cardiovascular disease and type 2 diabetes.
For more information, please contact:
Stefan K. Nilsson, CEO, Lipigon Pharmaceuticals AB
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 17:00:00 PM CET, on 19 January 2022.
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. Lipigons initial focus is 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 four active projects: the RNA-drug Lipisense for the treatment of hypertriglyceridemia, an RNA drug for the treatment of acute respiratory distress syndrome, a gene therapy treatment for the rare disease lipodystrophy in collaboration with Combigene AB (publ), 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.