Lipigon Pharmaceuticals AB (“Lipigon”), which develops drugs for diseases caused by disorders in the body’s handling of fats, announced earlier this week that they have chosen LINK Medical, a Nordic contract research organization (CRO) for the planning and design of their clinical phase II study with Lipisense. The study aims to study safety and treatment effects in patients with severely elevated levels of the blood fat triglyceride.
May 29, 2023
The primary objective of the study is to investigate safety in patients with triglycerides above 5 mmol/L, a condition known as severe hypertriglyceridemia (SHTG). In addition, the treatment effect and the body’s turnover of the drug candidate will also be studied. LINK Medical’s team in Uppsala will support Lipigon to conduct the first clinical phase II study with patients in the Lipisense project.
Lipigon’s drug candidate Lipisense is an antisense oligonucleotide (ASO) that prevents the body’s production of the protein ANGPTL4. By preventing protein activity, you increase the body’s ability to break down blood fats, such as triglycerides. The Lipisense project utilizes this to treat patients with SHTG, who are at increased risk of acute pancreatitis and cardiovascular disease.
“The collaboration with Link is a crucial step in the process of planning and applying for our clinical phase II study with Lipisense. For the first time, we will study our candidate substance in a patient group. LINK has extensive experience in planning and conducting phase II studies. The next step will be to design the details of the study and submit an application to the Medical Products Agency for implementation. Our goal is to apply as soon as possible after the completion of the ongoing phase I study and then start phase II in Q4 2023”, says Stefan K. Nilsson, CEO of Lipigon.
“We are proud to be allowed to work as a partner with Lipigon to help shape and conduct this important study with a novel oligonucleotide treatment for severe hypertriglyceridemia. It is always exciting to work on cutting-edge projects that have the potential to change the lives of people living with severe conditions. Lipigon is going where no one has gone before and we are proud to have been chosen as the full-service CRO to make the journey possible and be allowed to come along for the ride.” said Rikard Reneland Medical Director at LINK Medical
About LINK Medical
LINK Medical is a Northern European drug and device development company with over 25 years of experience in partnering with pharmaceutical, biotech, and medtech companies.
We offer end-to-end solutions across all product development areas, from pre-to post-marketing. Our services include Clinical Development (CRO), Project Management, Biostatistics, Regulatory Affairs, Quality Assurance (QA), Chemistry Manufacturing and Controls (CMC) development, Pharmacovigilance, Market Access, and Real-World Evidence among other services.
Lipigon Pharmaceuticals AB is a clinical-stage pharmaceutical company that develops 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. Lipigon initially focuses on rare diseases that can give orphan drug status and on niche indications, but in the long term the company has the opportunity to target broader indications in the area, such as diabetes and cardiovascular disease. Lipigon’s pipeline consists of four active projects: the RNA drug Lipisense for elevated triglycerides, which entered clinical phase in spring 2022, an RNA drug project for acute respiratory distress syndrome, a gene therapy project for the treatment of the rare disease lipodystrophy together with Combigene AB (publ) and a small molecule project for the treatment of dyslipidemia (general blood lipid disorders) in collaboration with HitGen Inc. Read more on www.lipigon.se.
The company’s share (LPGO) is traded on Nasdaq First North Growth Market. Certified Adviser is G&W Fondkommission.
For more information, please contact Stefan K. Nilsson, CEO, LipigonE-mail: stefan[@]lipigon.se
Phone: 0705-78 17 68
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