Delving into the Latest Updates on Omega-3-acid ethyl esters(Trygg Pharma AS) with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Lotriga Granular, Omega-3 fatty acid ethyl esters, OMEGA-3-ACID ETHYL ESTERS

+ [18]

Target

Lipid x Triglyceride

Mechanism

Lipid modulators, Triglyceride modulators

Therapeutic Areas

Congenital DisordersEndocrinology and Metabolic DiseaseOther Diseases+ [2]

Active Indication

HyperlipidemiasHyperlipoproteinemia Type IHypertriglyceridemia+ [2]

Inactive Indication

Acute myocardial infarctionCarotid StenosisDeath, Sudden, Cardiac+ [2]

Originator Organization

Trygg Pharma AS

Active Organization

BASF Corp.Pronova BioPharma ASAViatris Pty Ltd.

+ [2]

Inactive Organization

Allergan Ltd. (Ireland)Pronova Biopharma Norge AS

Abbott Laboratories Trading (Shanghai) Co. Ltd.

+ [6]

Drug Highest PhaseApproved

First Approval Date

US (10 Nov 2004),

Hypertriglyceridemia

Regulation-

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Structure/Sequence

Molecular FormulaC46H70O4

InChIKeyDTMGIJFHGGCSLO-FIAQIACWSA-N

CAS Registry861006-80-6

The lack of effective protection against UVB radiation, that severely disrupts the metabolism of keratinocytes, underlines the search for bioactive compounds that would provide effective protection without causing side effects. Therefore, the aim of the study has been to assess the effect of two compounds, that are different in terms of structure and properties: 3-O-ethyl ascorbic acid-EAA (a stable derivative of vitamin C) and cannabigerol-CBG, used separately or concurrently, on the metabolism of keratinocytes previously exposed to UVB. The obtained results indicate diverse, yet mutually reinforcing localization of the tested compounds, both within the membrane structures and cytosol. When used concurrently, EAA + CBG effectively prevent modifications of the structure of cell membranes, particularly the increase in their fluidity and permeability caused by UVB. It promotes cell survival and enhances the expression of membrane transporters, especially BCRP. Moreover, the concurrent use of both compounds, by reducing the level of ROS and regulating the expression of both Nrf2 activators (p62, MAPK) and inhibitors (Keap1, Bach1, PAGM5), supports the antioxidant efficiency of cells, visible in the increased activity of antioxidant enzymes (SOD1/2, CAT) and the effectiveness of GSH- and Trx-dependent antioxidant systems. Consequently, oxidative modifications of lipids (assessed as 4-HNE and isoprostanes) and proteins (measured as 4-HNE-protein adducts and carbonyl groups) are reduced. The tested compounds also reveal anti-inflammatory effects by modifying the expression of the activator (p62) and inhibitors (IKKα, IKKβ) of NFκB. The observed EAA + CBG effect in preventing changes in the structure and functionality of keratinocyte membranes, maintaining redox balance, and mitigating inflammatory effects caused by UVB provides the basis for further research.

01 Nov 2024·AACE clinical case reports

Unmasking a Rare Genetic Mutation: The Importance of Genetic Testing in Refractory Hypertriglyceridemia

Article

Author: Fanaropoulou, Nina Maria ; Theodoropoulos, Panagiotis ; Manessis, Anastasios

Background/Objective:

Genetic causes of hypertriglyceridemia like familial chylomicronemia syndrome can be overlooked in everyday practice. We report a patient with a rare genetic mutation, highlighting the importance of genetic testing for timely diagnosis and prevention of complications.

Case Report:

A 45-year-old Hispanic female presented with serum triglyceride levels of 749 mg/dL, refractory to rosuvastatin 10 mg daily and omega-3 ethyl esters 2 g daily. Initial studies showed total cholesterol of 278 mg/dL and high-density lipoprotein of 38 mg/dL. Physical examination was negative for hepatosplenomegaly and xanthoma, with no reported history of acute pancreatitis. Despite treatment escalation with gemfibrozil, fenofibrate, and icosapent ethyl, her triglyceride levels remained elevated, peaking at 4300 mg/dL. Seven years after presentation, genetic testing revealed homozygosity for c.11delC of the apolipoprotein A5 gene, confirming the diagnosis of familial chylomicronemia syndrome. Postdiagnosis, the patient adhered to a strict low-fat diet with daily fat intake of less than 15-20 g, limited simple sugars, refined carbohydrates, and alcohol, leading to a nadir of serum triglycerides of 197 mg/dL.

Discussion:

The identified mutation is exceedingly rare (<0.01%), as most associated mutations involve the lipoprotein lipase gene. There are no approved therapies for genetic hypertriglyceridemia. The mainstay of treatment is a very low-fat diet to prevent complications.

Conclusion:

We underscore the importance of genetic testing in refractory hypertriglyceridemia despite a lack of clinical signs. A definitive diagnosis can alleviate patient burden, improve therapeutic adherence, and enhance the patient-physician relationship.

01 Nov 2024·Journal of Atherosclerosis and Thrombosis

Comparison of Efficacy between Pemafibrate and Omega-3-Acid Ethyl Ester in the Liver: the PORTRAIT Study

Article

Author: Sumida, Yoshio ; Sakamoto, Kazumasa ; Yoneda, Masashi ; Kimoto, Satoshi ; Ito, Kiyoaki ; Toyoda, Hidenori ; Yasuda, Satoshi ; Osonoi, Takeshi ; Nakade, Yukiomi

AIM:

No pharmacotherapeutic treatment has been established for metabolic dysfunction-associated steatotic liver disease (MASLD) and metabolic dysfunction-associated steatohepatitis (MASH). This trial compared the effects of pemafibrate and omega-3-acid ethyl ester on hepatic function in patients with hypertriglyceridemia complicated by MASLD.

METHODS:

Patients with hypertriglyceridemia complicated by MASLD were enrolled, randomly assigned to the pemafibrate or omega-3-acid ethyl ester group, and followed for 24 weeks. The primary endpoint was the change in alanine aminotransferase (ALT) from baseline to week 24. The secondary endpoints included other hepatic enzymes, lipid profiles, and hepatic fibrosis biomarkers.

RESULTS:

A total of 80 patients were enrolled and randomized. The adjusted mean change in ALT from baseline to week 24 was significantly lower in the pemafibrate group (-19.7±5.9 U/L) than in the omega-3-acid ethyl ester group (6.8±5.5 U/L) (intergroup difference, -26.5 U/L; 95% confidence interval, -42.3 to -10.7 U/L; p=0.001). Pemafibrate significantly improved the levels of other hepatic enzymes (aspartate aminotransferase and gamma-glutamyl transpeptidase), lipid profiles (triglycerides, total cholesterol, high-density lipoprotein cholesterol, and non-high-density lipoprotein cholesterol), and hepatic fibrosis biomarkers (Mac-2 binding protein glycan isomer and Fibrosis-4 index). No cases of discontinuation due to adverse drug reactions were identified in either group, and there were no safety concerns.

CONCLUSIONS:

Pemafibrate is recommended over omega-3-acid ethyl ester for lipid management and MASLD treatment in patients with hypertriglyceridemia complicated by MASLD. The study results may contribute to the development of future treatment strategies for patients with MASLD/MASH.

61

News (Medical) associated with Omega-3-acid ethyl esters(Trygg Pharma AS)

19 Dec 2024

·www.businesswire.com

Marea Therapeutics Expands Management Team and Board of Directors

SAN FRANCISCO--( BUSINESS WIRE )--Marea Therapeutics, Inc., a clinical-stage biotechnology company harnessing the latest advances in human genetics to develop first-in-class, next-generation medicines for cardiometabolic diseases, today announced additions to its management team and board of directors. “Momentum continues to build at Marea as we advance our lead program, MAR001, through clinical development,” said Josh Lehrer, M.D., M.Phil., FACC, chief executive officer of Marea. “We are pleased to welcome Rebecca and Max to our leadership team and Robert to our board of directors. Their collective experience and expertise will be important as Marea enters its next phase of growth.” Rebecca Juliano, Ph.D., Appointed as Chief Development Officer Dr. Juliano has been in lipid-related research for more than 25 years and brings to Marea industry leadership experience across clinical program design, execution and communication. Most recently, Dr. Juliano served as chief operating officer at a stealth biotech startup, where she shaped teams and clinical programs for cardiovascular and rare disease indications. Prior to that, she led the clinical and related teams at Amarin Pharma, which were responsible for the cardiovascular outcomes trial REDUCE-IT, which received global approvals, led to changes in at least 15 global clinical guidelines, and received numerous accolades such as being named a top clinical trial by AHA, ACC and NEJM. Dr. Juliano began her industry career at Reliant Pharmaceuticals with the launch of Lovaza, and she has served multiple leadership and transitional consulting roles across her career. Prior to joining industry, Dr. Juliano was an AHA fellow at Weill Cornell Medical Center. She holds a Ph.D. from Columbia University and earned a B.S. in chemistry from the University of California, Santa Cruz. Max Zeiberg Appointed as Senior Vice President, Corporate Development Mr. Zeiberg most recently served as vice president, business development at Sana Biotechnology and at Graphite Bio, where he led partnering, strategic planning, and contributed to Graphite's Series B and IPO financings. Prior to that, Mr. Zeiberg held roles of increasing responsibility on the corporate development team at Gilead Sciences, culminating as head of virology partnering and M&A. During his time at Gilead, he successfully led numerous strategic transactions to build the company’s pipeline. Mr. Zeiberg began his career advising life science companies on commercial strategy and pipeline prioritization as a management consultant with ZS Associates. Mr. Zeiberg holds a B.S. in biomedical engineering from Columbia University and an MBA from the Kellogg School of Management at Northwestern University. Robert A. Harrington, M.D., Appointed to Board of Directors Dr. Harrington is a cardiologist and serves as the Stephen and Suzanne Weiss Dean of Weill Cornell Medicine and provost for medical affairs of Cornell University. His research areas of focus include evaluating antithrombotic therapies to treat acute ischemic heart disease and to minimize the acute complications of percutaneous coronary procedures, and trying to better understand and improve upon the methodology of clinical research, including the use of technologies to facilitate the conduct of clinical trials. Dr. Harrington was the Arthur L. Bloomfield Professor and chair of the Department of Medicine at Stanford University for more than 10 years. He previously served as the Richard Stack Distinguished Professor and the director of the Duke Clinical Research Institute at Duke University, where he completed his fellowship in general and interventional cardiology. Dr. Harrington holds a Bachelor’s degree in English from the College of the Holy Cross and an M.D. from Tufts University School of Medicine. He served as chief resident during his residency in internal medicine at the University of Massachusetts Medical Center in Worcester. About Marea Therapeutics Marea Therapeutics is a clinical-stage biotechnology company harnessing the latest advances in human genetics to develop first-in-class, next-generation medicines for cardiometabolic diseases. The company’s lead program, MAR001, is in Phase 2 clinical development for adults with metabolic dysfunction and high risk for cardiovascular disease. Marea is led by a dynamic team of scientists and company builders with deep know-how and experience in cardiometabolic diseases, human genetics and adipocyte biology. To learn more, please visit www.mareatx.com and follow us on LinkedIn and X .

Executive ChangePhase 2

05 Nov 2024

·www.drugs.com

Fish Oil Supplements Might Help Prevent Cancer

TUESDAY, Nov. 5, 2024 -- The omega-3 and omega-6 fatty acids in fish oil supplements might help protect people from cancer , a new study claims. Study participants with higher levels of omega-3s had lower rates of colon , stomach, lung and other digestive tract cancers, researchers found. Likewise, high omega-6 levels led to lower rates of 14 different cancers, including brain, melanoma, bladder and more, result showed. “These findings suggest that the average person should focus on getting more of these fatty acids in their diets,” said lead researcher Yuchen Zhang , a doctoral student with the University of Georgia’s College of Public Health. The study relied on data from more than 253,000 participants in the UK Biobank research project. As part of that project, participants filled out dietary questionnaires and had their health tracked for decades. Of those people, nearly 30,000 developed some form of cancer, researchers said. Importantly, the benefits of high levels of fatty acids were independent of other cancer risk factors like BMI, alcohol use or physical activity. These fatty acids are present in fatty fish, nuts and plant-based cooking oils, but many people turn to fish oil supplements to make sure they’re getting enough. However, the benefits of these fatty acids aren’t universal. The researchers noted that high omega-3 levels could be associated with a slightly higher risk of prostate cancer. “For women, it’s an easy decision: Eat more omega-3,” researcher Kaixiong Ye , an associate professor in UGA’s Franklin College of Arts and Sciences, said in a university news release. The new study was published recently in the International Journal of Cancer . Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

02 Aug 2024

·www.drugs.com

Fish Oil Might Help High-Risk Older Adults Avoid Alzheimer's

FRIDAY, Aug. 2, 2024 -- Fish oil supplements might help high-risk seniors stave off Alzheimer’s disease, a new study finds. Older people with a higher genetic risk of Alzheimer’s experienced slower breakdown of their brain’s nerve cells if they took fish oil capsules, researchers reported Aug. 1 in the journal JAMA Network Open . These people carry the APOE4 gene variant, which increases risk of Alzheimer’s and is associated with an earlier age of onset, according to the National Institute on Aging. “The fact that neuronal integrity breakdown was slowed in people randomized to omega-3 treatment who are also at high risk for Alzheimer’s disease is remarkable, and warrants a larger clinical trial in more diverse populations in the future,” said researcher Gene Bowman , a neurology instructor with the McCance Center for Brain Health at Massachusetts General Hospital in Boston. However, fish oil supplements did not benefit all seniors in general, researchers noted. “Our findings showed that over three years, there was not a statistically significant difference between placebo and the group that took fish oil,” said researcher Dr. Lynne Shinto , a professor of neurology with the Oregon Health & Science University School of Medicine. “I don’t think it would be harmful, but I wouldn’t say you need to take fish oil to prevent dementia.” For the study, researchers recruited 102 people ages 75 and older who had relatively low levels of omega-3 fatty acids, the beneficial ingredient in fish oil. Fish oil supplements are touted as a means of improving brain function in people with memory problems, researchers said in background notes. Participants received MRI brain scans at the start of the study and after three years looking for white matter lesions in the brain. All had relatively high levels of white matter lesions but were otherwise healthy, with no dementia. These lesions can inhibit the ability of blood vessels to feed brain cells, increasing a person’s future risk of dementia, researchers said. Half the participants were asked to take daily fish oil supplements, and the other half took a soybean-based placebo. The MRI scans found a slight reduction in the progression of white matter lesions among people who took fish oil, but not enough to be statistically significant, researchers said. However, APOE4 carriers who took fish oil experienced a dramatic reduction in the breakdown of their brain cell integrity as soon as one year after starting on fish oil, compared to the placebo group. “This is the first dementia prevention trial to use modern prevention tools, such as a blood test and brain scan, to identify not only people at high risk for dementia, but also those well-suited to receive a specific nutritional intervention,” Bowman said. Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

100 Deals associated with Omega-3-acid ethyl esters(Trygg Pharma AS)

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External Link

KEGG	Wiki	ATC	Drug Bank
D05255	Omega-3-acid ethyl esters(Trygg Pharma AS)	C10AX06	DB09539

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Hyperlipidemias	JP	Takeda Pharmaceutical Co., Ltd.	28 Sep 2012
Hyperlipoproteinemia Type I	AU	Viatris Pty Ltd.	05 Aug 2010
Hypertriglyceridemia	US	Woodward Pharma Services LLCStartup	10 Nov 2004

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Hyperlipoproteinemia Type IV	Phase 3	CN	AbbVie Pharmaceuticals GmbH	19 Sep 2016
Hyperlipoproteinemia Type IV	Phase 3	CN	Pronova Biopharma Norge AS	19 Sep 2016
Hyperlipoproteinemia Type IV	Phase 3	CN	GMPack ApS	19 Sep 2016
Hyperlipoproteinemia Type IV	Phase 3	CN	Abbott Laboratories Trading (Shanghai) Co. Ltd.	19 Sep 2016
Hyperlipoproteinemia Type II	Phase 3	NO	Pronova BioPharma ASA	01 Mar 2013
Cardiovascular Diseases	Phase 3	US	BASF Corp.	01 Jul 2010
Cardiovascular Diseases	Phase 3	US	Pronova BioPharma ASA	01 Jul 2010
Neoplasms	Phase 3	US	BASF Corp.	01 Jul 2010
Neoplasms	Phase 3	US	Pronova BioPharma ASA	01 Jul 2010
Acute myocardial infarction	Phase 3	DE	Pronova BioPharma ASA	01 Oct 2003

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04181593 (CTgov)	Phase 3	Dry Eye Syndromes	322	Omega 3 fatty acid (OmegaD)	uhzvmmuvyc(xmympyrptd) = fdwevwijjt vxwehlvrpk (gjfxrfwoec, mpyvoczzxw - absfkiyeba) View more	-	29 Jul 2024
				Placebos (Placebo)	uhzvmmuvyc(xmympyrptd) = tlidjmsxug vxwehlvrpk (gjfxrfwoec, yyltheatqf - tkzfisrxqy) View more
ENDO2024	Not Applicable	Hypertriglyceridemia	-	Lovaza 2gm AM and 2gm PM	uueakutkrr(daoknkfrep) = yniyrlnbak pkhrinttxz (ydcozpehxh )	-	01 Jun 2024
				Synthroid 220 mcg IV daily	uueakutkrr(daoknkfrep) = qqrfkyfzjm pkhrinttxz (ydcozpehxh )
NCT00746811 (CTgov)	Phase 4	Primary hypercholesterolemia	32	P-OM3 (P-OM3)	wxkkvwfdtf(ncpmlxpbtw) = heeikkwbyf jsqvnqnrnj (vaurfpibgs, xooepcglae - fntkoflvra) View more	-	08 May 2024
				Placebo (Placebo)	wxkkvwfdtf(ncpmlxpbtw) = jndpcaarcs jsqvnqnrnj (vaurfpibgs, dafyflkvwr - xdyqoudzee) View more
AASLD2023	Not Applicable	-	-	Fenofibrate	qjyxuqjrrk(eagaiphgmn) = rfsbbtfpsz tfajjzrdcr (gomucbreya ) View more	-	10 Nov 2023
				Bezafibrate	qjyxuqjrrk(eagaiphgmn) = jfijhxgnwz tfajjzrdcr (gomucbreya ) View more
NCT04198805 (PUVENAFLD, CTgov)	Phase 2	Insulin Resistance \| Nonalcoholic Steatohepatitis \| Hypertension	205	Omega-3 fatty acid+Vitamin E (DHA EE (1.89 g) and Vitamin E (1000 mg))	cmombifahx(abnwenjnto) = njjmdjmqxf vqqnxyzxzr (nctrmiongq, udtpkomgqo - ngazruhoxj) View more	-	25 May 2023
				Placebo (Placebo)	cmombifahx(abnwenjnto) = gtyelhkjgx vqqnxyzxzr (nctrmiongq, unqtakscfu - xdokjtkdps) View more
NCT03345550 (OPTIMA, CTgov)	Phase 2	Brain Concussion	44	Omega-3 Polyunsaturated Fatty Acids (Fish Oil 1000 mg (contains 500 mg DHA & 100 mg EPA)) or placebo capsules. (Omega-3 Polyunsaturated Fatty Acid Treatment Arm)	bbmlfhkaxr(puhwfaqlfm) = hodfemgkzh xizkezpweh (cbhzhahhqj, fucjllsbns - mtualkyilm) View more	-	23 May 2023
				Placebo - Cap (Placebo Arm)	bbmlfhkaxr(puhwfaqlfm) = pawarzbtjg xizkezpweh (cbhzhahhqj, slewpfwool - azdtdnzlaw) View more
NCT01669915 (VITAL-Cog, CTgov)	Not Applicable	Cognitive Dysfunction	3,424	Vitamin D (TELEPHONE INTERVIEW ANCILLARY STUDY: Active Vitamin D)	vgqcjoynaw(blxvfuzmem) = kebhljuanh pjpwzxfdsu (avcgoaqikt, iayqyrszop - kecxouuwto) View more	-	21 Apr 2023
				Vitamin D (TELEPHONE INTERVIEW ANCILLARY STUDY: Vitamin D Placebo)	vgqcjoynaw(blxvfuzmem) = syfqaviyzv pjpwzxfdsu (avcgoaqikt, daoijoucas - qnthukrebt) View more
NCT01813006 (EUDRACTNR 2012-000505-68, Pubmed \| Scand J Clin Lab Invest)	Phase 3	Hyperlipoproteinemia Type II	34	Omega-3 polyunsaturated fatty acid supplement	yiirvyjxpx(ifbgcfondx) = jvusdjvwyb nlucivlykz (zhloonvrvp, [ - 13, 6])	-	31 Mar 2023
NCT01696435 (VITAL \| VITAL-DEP, CTgov)	Not Applicable	Depressive Disorder	18,353	vitamin D3 (Vitamin D + Fish Oil Placebo)	muxybwpnlk(bgsljogcix) = irisnbflbn urpchezwcn (chkckgcirt, qybkbozqql - uppxtvnrec) View more	-	14 Mar 2023
				Vitamin D placebo+omega-3 fatty acids (fish oil) (Vitamin D Placebo + Fish Oil)	muxybwpnlk(bgsljogcix) = mjkxfsyrda urpchezwcn (chkckgcirt, qqryvdogtz - eulzdgfbfn) View more
NCT04495816 (CTgov)	Phase 2	COVID-19 \| Anosmia	139	Omega-3 Fatty Acid Supplement (Omega-3)	vzpottuvfq(jtqxlkxhur) = mvrsiozjig guxaezrguh (hazzpqebds, leivadtlpc - dpgbtmqply) View more	-	31 Jan 2023
				Placebo/Control (Placebo/Control)	vzpottuvfq(jtqxlkxhur) = pijhosjhxw guxaezrguh (hazzpqebds, sgnlrsvtvv - kuabhidnsd) View more