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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SOURCE AMPEL BioSolutions