Aker BioMarine, in collaboration with the Lupus Research Alliance, is launching the first clinical trial to assess the therapeutic activity and benefits of fatty-rich krill oil in people with systemic lupus erythematosus (SLE).
The trial (NCT03626311), which is not recruiting yet, is expected to enroll about 76 adults with a confirmed lupus diagnosis at 20 sites in the U.S. and Canada. To be included in the study, patients must have a low regular consumption of fatty fish and seafood, defined as two or less times per month.
Participants will be randomized to receive a daily dose of 4 g of AKBM-3031, which are phospholipid-rich krill oil capsules, or a placebo fatty mixture, as a dietary supplement for six months. This will be followed by a six-month open-label extension study, in which both groups will be given the krill oil capsules at the same dosage.
“This trial reflects our responsiveness to patient wishes — a treatment that is safe and has the potential to attenuate lupus disease as well as the associated cardiovascular complications associated with it,” Jane Salmon, MD, the coordinating investigator of the study, said in a press release. She is the director of the Lupus and APS Center of Excellence and co-director of the Mary Kirkland Center for Lupus Research at the Hospital for Special Surgery in New York.
The primary aim of the study is to evaluate changes in the levels of blood omega-3 and omega-6 fat molecules over the course of the study period. Researchers will also assess the effects of the AKBM-3031 supplements on lupus-related immune response, as well as on patients’ clinical outcomes and quality of life.
Results of the study are expected to be announced in 2020.
“We are so excited that molecules from krill can potentially reduce the symptoms associated with lupus,” said Matts Johansen, CEO of Aker BioMarine. “There has been only one new drug developed to treat lupus in 60 years, which is why we are going all in to dedicate our resources to try to provide a natural alternative for people with lupus.”
Krill are ocean creatures resembling tiny shrimp that feed on microalgae. They are the main food source for animals such as fish, penguins, and whales. Because they are at the bottom of the food chain, harvesting krill has a low ecological impact on the planet. Aker, which is a leading supplier of krill, also takes steps to ensure responsible harvesting, the company says.
Krill oil is very rich in Omega-3 fatty acids such as eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). These compounds are known to be good for the health, playing a critical role in managing inflammation. In addition, krill oil also has a naturally occurring nutrient called astaxanthin, a potent antioxidant that protects omega-3 fatty acids and keep them stable and active longer.
Aker BioMarine’s krill oil is extracted using a unique method that increases the levels of a group of fatty molecules called phospholipids, which can enhance and assist in the absorption of omega-3 fatty molecules by the body.
Prior studies have demonstrated that omega-3 rich oils can help ease lupus symptoms and improve patients’ quality of life by reducing overall inflammation and fatigue.
“We are very pleased to work with Aker BioMarine on bringing a potential therapeutic option to people with lupus,” said Kenneth M. Farber, president and CEO of the Lupus Research Alliance. “The company is thoroughly testing the effectiveness of krill for this group of patients through well-designed scientifically rigorous clinical studies.”
For more information, visit the study’s web page here.