icosapent (MND-2119) / Mochida, Amarin - LARVOL DELTA

PEER simplified lipid guideline 2023 update: Prevention and management of cardiovascular disease in primary care. (PubMed, Can Fam Physician) - "These updated evidence-based guidelines provide a simplified approach to lipid management for the prevention and management of CVD. These guidelines were created by and for primary health care professionals and their patients."

Journal • Cardiovascular • APOB

Enhanced Production of EPA-Derived Anti-Inflammatory Metabolites after Oral Administration of a Novel Self-Emulsifying Highly Purified EPA Ethyl Ester Formulation (MND-2119). (PubMed, J Atheroscler Thromb) - "These results demonstrate that MND-2119 increases the plasma and cellular concentrations of EPA and EPA-derived metabolites to a greater extent than conventional EPA-E formulations."

Journal • Atherosclerosis • Cardiovascular • Dyslipidemia • Inflammation

Quantitative structural-activity relationship (QSAR) models for multitargets of Alzheimer's disease for drug repurposing (ACS-Fall 2023) - "7 of the predicted drugs are consistent with previous evidence, including 6 on Phase 2 (icosapent, levetiracetam, nicotine) and 3 (metformin, hydralazine, guanfacine) AD clinical trials and 1 approved by FDA for AD symptom relief (donepezil). The results of these virtual screens will be followed by pharmacoepidemiologic analyses using real-world data (US Medicare claims) to test the effectiveness of these DR candidates on preventing incident dementia and slowing the progress of AD."

Alzheimer's Disease • CNS Disorders • Dementia

Severe Hypertriglyceridemia Post Liver Transplant- a Multifactorial Disorder (ENDO 2023) - "Intravenous insulin infusion was initiated with moderate improvement however, upon transition to oral medications: fenofibrate, omega-3 fatty acids, niacin and rosuvastatin, TGs continued to increase...Post-discharge, the patient was changed back to previous TAC dosage due to cyclosporin related renal injury. His steroid dose was reduced and icosapent was added, resulting in no further recurrence of HTG. Following liver transplant, about 15-40% recipients have increased cholesterol levels and about 40% have HTG...Abstracts presented at a news conference are embargoed until the date and time of the news conference. The Endocrine Society reserves the right to lift the embargo on specific abstracts that are selected for promotion prior to or during ENDO.*"

Atherosclerosis • Cardiovascular • Dyslipidemia • Fibrosis • Gastroenterology • Hepatology • Hypertriglyceridemia • Immunology • Liver Cirrhosis • Metabolic Disorders • Nephrology • Pancreatitis • Pediatrics • Solid Organ Transplantation • Transplantation

"Trigliceridi elevati, nuove conferme per icosapent etile nei pazienti con recente sindrome coronarica acuta #ACC23 https://t.co/cvOroq5f6a" (@PharmaStar)

Icosapent ethyl alleviates acetic acid-induced ulcerative colitis via modulation of SIRT1 signaling pathway in rats. (PubMed, Int Immunopharmacol) - "Ulcerative colitis (UC) is a global inflammatory bowel disease. Icosapent effects were antagonized by EX527. Icosapent alleviated acetic acid-induced colitis via its anti-inflammatory, antioxidant, and anti-apoptotic effects mediated in part by SIRT1 pathway activation."

Journal • Preclinical • Anesthesia • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Oncology • Ulcerative Colitis • CASP3 • HMOX1 • IL1B • TNFA • TP53

Long-term safety and efficacy of MND-2119 (self-emulsifying formulation of highly purified eicosapentaenoic acid ethyl ester) in patients with hypertriglyceridemia: Results from a multicenter, 52-week, open-label study. (PubMed, J Clin Lipidol) - "Long-term administration of MND-2119 was not associated with any safety-related problems. TG levels decreased by Week 4, and the TG reducing effect continued up to Week 52."

Journal • Dyslipidemia • Hypertriglyceridemia • Metabolic Disorders

Pharmacokinetics of Single and Multiple Oral Administration of a Self-emulsifying Formulation of Highly Purified Eicosapentaenoic Acid Ethyl Ester (MND-2119) Compared With the Nonself-emulsifying Formulation in Healthy Male Subjects. (PubMed, Clin Pharmacol Drug Dev) - "No safety-related issues occurred in either study. These results suggest that MND-2119 administered once daily may achieve equivalent or higher plasma EPA concentrations compared to the nonself-emulsifying formulation administered twice daily."

Journal • PK/PD data

Efficacy and safety of self-emulsifying formulation of highly purified eicosapentaenoic acid ethyl ester (MND-2119) versus highly purified eicosapentaenoic acid ethyl ester in patients with hypertriglyceridemia: Results from a 12-week randomized, double-blind, active-controlled, phase 3 study. (PubMed, J Clin Lipidol) - "Non-inferiority of MND-2119 2 g/day to EPA-E 1.8 g/day for efficacy, and superiority of MND-2119 4 g/day over MND-2119 2 g/day for efficacy were verified. MND-2119 was safe and well tolerated."

Clinical • Journal • P3 data • Dyslipidemia • Hypertriglyceridemia • Metabolic Disorders

"Icosapent better than #empagliflozin @Boehringer or #iPCSK9 @AmgenSpain" (@FerrerasPastor)

Long-term Safety and Efficacy Study of MND-2119 in Patients With Hypertriglyceridemia (clinicaltrials.gov) - P3; N=120; Completed; Sponsor: Mochida Pharmaceutical Company, Ltd.; Active, not recruiting ➔ Completed

Clinical • Trial completion • Dyslipidemia • Hypertriglyceridemia

"Any consideration for omega-3 FA or icosapent as adjunctive therapy?" (@gutwat1)

[VIRTUAL] Triglycerides, Icosapent for Non-Triglyceride Risk Reduction and Lp (AACE 2021) - "Learning Objectives: Assess the key differences between REDUCE-IT and STRENGTH CV Outcomes Trials Select patients in whom pure prescription EPA (icosapent ethyl) has been proven to reduced CVD (all of the following): (a) At high CVD risk (prior event or DM2+ other risk factors) (b) Taking a statin (c) With controlled LDL-C, but with (d) Residual TG-elevation (> 135 mg/dL)Implement the use of pure prescription EPA (icosapent ethyl) in CVD prevention in these selected patients"

PREPARE-IT. Prevention of COVID19 With EPA in Healthcare Providers at Risk - Intervention Trial (clinicaltrials.gov) - P3; N=1500; Not yet recruiting; Sponsor: Estudios Clínicos Latino América

New P3 trial • Infectious Disease • Novel Coronavirus Disease • CRP

Long-term Safety and Efficacy Study of MND-2119 in Patients With Hypertriglyceridemia (clinicaltrials.gov) - P3; N=120; Active, not recruiting; Sponsor: Mochida Pharmaceutical Company, Ltd.; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Dyslipidemia • Hypertriglyceridemia

Long-term Safety and Efficacy Study of MND-2119 in Patients With Hypertriglyceridemia (clinicaltrials.gov) - P3; N=120; Recruiting; Sponsor: Mochida Pharmaceutical Company, Ltd.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open

Long-term Safety and Efficacy Study of MND-2119 in Patients With Hypertriglyceridemia (clinicaltrials.gov) - P3; N=120; Not yet recruiting; Sponsor: Mochida Pharmaceutical Company, Ltd.

Clinical • New P3 trial