First Patient Dosed in Phase II Clinical Trial of Lipisense®
LINK Medical announces a major milestone in collaboration with Lipigon Pharmaceuticals

November 21, 2024 – LINK Medical is proud to announce the successful dosing of the first patient in the Phase II clinical trial of Lipigon Pharmaceuticals’ groundbreaking RNA therapeutic, Lipisense®. As the contract research organization (CRO) managing the trial, LINK Medical oversees all aspects of clinical operations, ensuring the study’s smooth execution and high standards.

The trial is being conducted at five sites across Sweden and represents a critical step toward developing effective treatments for patients suffering from moderate to severe hypertriglyceridemia with underlying type 2 diabetes. Hypertriglyceridemia significantly increases the risk of acute pancreatitis and cardiovascular diseases, posing severe global health challenges.

“At LINK Medical, we are honored to support the advancement of innovative therapies like Lipisense®, addressing critical unmet medical needs. Reaching this milestone is a testament to our clinical expertise and the strong partnership with Lipigon Pharmaceuticals,” said Sissel Lønning Andresen, CEO of LINK Medical. “Our dedicated team remains focused on ensuring excellence in every phase of clinical development.”

About the Phase II Clinical Trial

This Phase II study aims to evaluate the safety profile of Lipisense® and its effects on various biomarkers, including triglycerides, insulin sensitivity, and remnant cholesterol. Remnant cholesterol is a key contributor to atherosclerosis and thus cardiovascular disease.

The trial will involve 26 patients receiving four doses of Lipisense® or a placebo over a one-month period, followed by a six-month observation phase. The successful dosing of the first patient is a major milestone in this critical development program.

Lipisense® is a liver-specific RNA therapeutic designed to inhibit the production of ANGPTL4, a protein that plays a significant role in lipid metabolism. By targeting ANGPTL4, Lipisense® enhances the body’s ability to clear plasma triglycerides, offering promising benefits for patients with severe lipid imbalances.

This milestone highlights the successful collaboration between LINK Medical and Lipigon Pharmaceuticals. Together, the teams are on track to complete patient recruitment before mid-2025, paving the way for the continued development of Lipisense®.

About Lipigon Pharmaceuticals

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. Lipigon initially focuses 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 three active projects: the RNA drug Lipisense® targeting elevated triglycerides, with Phase II studies approved in February 2024; an RNA drug for treating lung damage; and a small molecule program for the treatment of dyslipidemia in collaboration with HitGen Inc. 

Read more at www.lipigon.se.

About LINK Medical

LINK Medical is a leading CRO and regulatory service provider, delivering expert-driven, innovative solutions for the pharmaceutical and medical device industries across Northern Europe and beyond. Founded in Oslo, Norway, in 1995 by Ola Gudmundsen, LINK Medical combines Nordic transparency and a commitment to high-quality service delivery, supporting all stages of product development through to post-marketing approval.

With one of the largest regulatory teams in the Nordics, LINK Medical provides tailored solutions for its clients, leveraging a network of experts and senior advisors to deliver proven results. The company’s dedication to integrity, respect, and customized solutions makes it a trusted partner for every step of the product development journey.

For more information, visit www.linkmedical.eu.

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