Lupus Treatment with Omega3-Rich Krill Oil Improves Disease Activity

CHARLOTTESVILLE, Va., July 15, 2024 /PRNewswire/ -- Today AMPEL BioSolutions, with collaborators Lupus Therapeutics and Aker Biomarine, revealed peer-reviewed results that supplementation with Omega3-rich Krill Oil improves disease activity of autoimmune Lupus patients.

Omega3 lipids called polyunsaturated fatty acids (PUFAs) that are found in microscopic shrimp-like crustaceans called Krill from the waters around Antarctica are key to maintaining a low inflammatory state. Some studies indicate that Krill contains Omega3 in an easily digested phospholipid form that may achieve more effective integration into cellular membranes compared with the triglyceride-rich form predominant in fish oil. And the concentrated Superba Boost Krill Oil (AKBM-3031) was highly ranked by the hypothesis-based CoLTs (Combined Lupus Treatment Scoring) published approach for testing in the ORKIDS clinical trial.

The question that today's publication addresses with the multicenter, randomized, double-blind, placebo-controlled ORKIDS trial was whether inflammatory disease activity of people living with Lupus was influenced with a "food as medicine" approach of Omega3 Krill Oil supplementation. The results indicate that Lupus patients have suboptimal omega-3 (measured in red blood cell membranes using the standard omega3 index) which was normalized by one month supplementation with Krill Oil. The normalization effect of Krill Oil supplementation persisted through 48weeks during the open label extension. Importantly, Krill Oil appeared to decrease Lupus disease activity in patients who were sicker at baseline (measured by the standard SLEDAI-2K greater than 9). Several patients experienced a sustained improvement in disease activity in parallel with improved omega-3 index.

Cardiovascular issues such as heart attack and stroke affect Lupus patients 5-10x more often than the general population and classic risk factors do not always contribute. Deficiency in omega-3 has been shown to contribute to increased risk of CVD. This study demonstrated that patients with lupus uniformly have depressed levels of omega-3 fatty acids and that Krill Oil supplementation safely returns omega-3 levels into a less risky range.

Dr. Peter Lipsky, AMPEL BioSolutions' Co-Founder, CEO and Chief Medical Officer, "The ORKIDS clinical trial of Krill Oil supplementation for Lupus was a team effort that documented patients were uniformly omega-3 fatty acid deficient which was reversible with Krill Oil supplementation. We are particularly grateful to the patient participants who represented Lupus across all ancestries including one-third identifying as African-Americans When the COVID pandemic closed clinical sites, patient participants persevered to ensure that the trial continued by monitoring their omega-3 levels at home with a blood finger prick that they mailed into the clinical trial lab. Success of this trial was largely dependent on the outstanding commitment and attention to detail of those living with Lupus who participated in this Krill Oil trial."

"Our mission is to improve human health, and since inception we have prioritized scientific investigations through R&D to understand the nutritional value and potential health benefits of Krill Oil nutrients," said Matts Johansen, CEO Aker BioMarine. "This new study with patients living with Lupus is one of the biggest investments we have contributed to in regard to clinical trials, and we are excited to see what the future holds."

"Research has shown that people with lupus are at an elevated risk of inflammation and cardiovascular complications," said Dr. Amrie Grammer, AMPEL BioSolutions' Co-Founder, President and CSO, "Increasing Omega-3 Index to an optimal level through Krill Oil supplementation may show benefit for this population and warrants further study."

"On behalf of LuCIN investigators, I am pleased to report the results of Krill Oil supplementation for Lupus which found that patients are, indeed, deficient in omega3 and this can be safely corrected," said Dr. Jane Salmon, ORKIDS Trial PI as well as NYC's HSS Dir Lupus Center of Excellence & Mary Kirkland Ctr for Lupus Research at Weill-Cornell, "With the concentrated Superba Boost preparation of Krill Oil, we were able to bring omega3 levels into the range of protection from cardiovascular disease and to improve disease activity in those with more active Lupus."

About AMPEL BioSolutions

AMPEL is a Precision Health company commercializing a development pipeline of blood tests that measure dynamic RNA gene expression providing a real-time CLIA-certified report of inflammation status including drugs targets that are abnormal. Unlike DNA tests which only need to be done once, AMPEL's RNA blood or biopsy tests are utilized on demand with the goal of "treat to target" and optimal disease management re forecast flares for Lupus (LuGENE^®) or Dermatology Conditions such as Psoriasis or Ezcema (DermaGENE^®). For an otherwise healthy individual, AMPEL's prediction of inflammation with WellGENE^® may be an early indicator of changes in the immune system that may be worth investigating further by a trained healthcare provider. In addition, AMPEL works with Pharma/Biotech customers as a CRO designing & operationalizing clinical trials as well as a biomarker partner for target identification, pre-clinical models, post-hoc analysis and real-time enrichment during clinical trial enrollment. The company's portfolio of tests are supported by the AMPEL Genomic Platform of RNA analytic tools and explainable predictive AI.

The support of Lupus Therapeutics and the LuCIN investigators is gratefully acknowledged, including the following investigators: Dan Wallace (Cedars-Sinai, UCLA), Violeta Rus (U. Maryland), Elena Massarotti (Brigham and Women's Hospital), Meggan Mackay (Feinstein Institute for Medical Research), Chaim Putterman (Albert Einstein College of Medicine), Cynthia Aranow , Sonali Narain (Northwell Health), Meenakshi Jolly (Rush Medical Center), Kyriakos Kirou (Hospital for Special Surgery), W. Winn Chatham (University of Alabama at Birmingham), Sheetal Desai (University of California Irvine Health), Maria F Carpintero (University of Miami), W Joseph McCune (University of Michigan Health System), Jennifer Anolik (University of Rochester Medical Center), Uma Thanarajasingam (Mayo Clinic), Jonathan Kay (UMass Memorial Medical Center), Narender Annapureddy (Vanderbilt Clinical Research Center), Francis Luk (Wake Forest Baptist Health), Christian Pineau (McGill University Health Centre, Montreal General Hospital), Mark Matsos (McMaster University Medical Center) and Christine Peschken (Shared Health operating the Health Sciences Centre, Winnipeg).

Background re Lipids and Inflammatory Signals
The body's immune system normally fights off infections, but the cells of an autoimmune individual are in a constant state of inflammation that specifically targets one's own tissues like kidneys. Cells receive information through their outer membrane and transmit signals to the DNA inside cells to turn genes on/off resulting in some change in cellular function. Inflammation is perpetuated at the cellular level when receptors in a cell's membrane do not return to a resting state and keep signaling for more inflammation. The composition of the lipids in cell membranes influence how quickly a cell returns to a resting state. Moreover, factors produced from membrane lipids plat an important role in resolving inflammation.

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