title: Effects of MAT9001 containing eicosapentaenoic acid and docosapentaenoic acid, compared to eicosapentaenoic acid ethyl esters, on triglycerides, lipoprotein cholesterol, and related variables.
abstract: Long-chain omega-3 fatty acid concentrate pharmaceuticals are used in the United States for treatment of severe hypertriglyceridemia (≥500 mg/dL) and are under investigation as adjuncts to statins for lowering cardiovascular risk in patients with high triglycerides (TGs; 200-499 mg/dL).
  
  
  
  To evaluate MAT9001, an investigational prescription-only omega-3 fatty acid agent containing predominantly eicosapentaenoic acid (EPA) and docosapentaenoic acid, in 42 men and women with fasting TG 200 to 400 mg/dL.
  
  
  
  In this open-label, crossover trial, subjects received MAT9001 and EPA ethyl esters (EPA-EE) in random order. They were housed in a clinical research unit for 2 14-day treatment periods, separated by a ≥35-day washout. Lipoprotein lipids, apolipoproteins (Apos) and proprotein convertase subtilisin kexin type 9 levels were measured before and at the end of each treatment period.
  
  
  
  MAT9001, compared with EPA-EE, resulted in significantly (P < .05) larger reductions from pretreatment levels for TG (-33.2% vs -10.5%), total cholesterol (-9.0% vs -6.2%), non-high-density lipoprotein cholesterol (-8.8% vs -4.6%), very low-density lipoprotein cholesterol (-32.5% vs -8.1%), Apo C3 (-25.5% vs -5.0%), and proprotein convertase subtilisin kexin type 9 (-12.3% vs +8.8%). MAT9001 also produced a significantly (P = .003) larger reduction in Apo A1 (-15.3% vs -10.2%), but responses for high-density lipoprotein cholesterol (-11.3% vs -11.1%), low-density lipoprotein cholesterol (-2.4% vs -4.3%), and Apo B (-3.8% vs -0.7%), respectively, were not significantly different relative to EPA-EE.
  
  
  
  MAT9001 produced significantly larger reductions than EPA-EE in several lipoprotein-related variables that would be expected to favorably alter cardiovascular disease risk in men and women with hypertriglyceridemia.
authors.affiliation: Midwest Biomedical Research/Center for Metabolic and Cardiovascular Health, Glen Ellyn, IL, USA. Electronic address: kmaki@mbclinicalresearch.com.
authors.forename: Kevin C
authors.initials: KC
authors.lastname: Maki
authors.affiliation: Matinas BioPharma, Inc., Bedminster, NJ, USA.
authors.forename: George
authors.initials: G
authors.lastname: Bobotas
authors.affiliation: Midwest Biomedical Research/Center for Metabolic and Cardiovascular Health, Glen Ellyn, IL, USA.
authors.forename: Mary R
authors.initials: MR
authors.lastname: Dicklin
authors.affiliation: Midwest Biomedical Research/Center for Metabolic and Cardiovascular Health, Glen Ellyn, IL, USA.
authors.forename: Margie
authors.initials: M
authors.lastname: Huebner
authors.affiliation: Department of Medicine, University of Minnesota (Retired), Minneapolis, MN, USA.
authors.forename: William F
authors.initials: WF
authors.lastname: Keane
mesh_terms: D000293:Adolescent; D000328:Adult; D002784:Cholesterol / Q000097:blood*; D015118:Eicosapentaenoic Acid / Q000031:analogs & derivatives* / Q000737:chemistry* / Q000494:pharmacology*; D005231:Fatty Acids, Unsaturated / Q000737:chemistry*; D005260:Female; D006801:Humans; D008074:Lipoproteins / Q000097:blood*; D008297:Male; D008875:Middle Aged; D014280:Triglycerides / Q000097:blood*; D055815:Young Adult
chemical_list: D005231:Fatty Acids, Unsaturated; D008074:Lipoproteins; D014280:Triglycerides; C030104:lipoprotein cholesterol; C035276:eicosapentaenoic acid ethyl ester; D002784:Cholesterol; D015118:Eicosapentaenoic Acid; C026219:docosapentaenoic acid
keywords: Docosapentaenoic acid; Eicosapentaenoic acid; Hypertriglyceridemia; Omega-3 fatty acids; Proprotein convertase subtilisin kexin type 9; Triglycerides