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Highly purified eicosapentaenoic acid, as free fatty acid, reduces fecal calprotectin levels and prevents clinical relapse in ulcerative colitis patients

A technology for ulcerative colitis and calprotectin, applied in the direction of eicosanoid active ingredients, anti-inflammatory agents, organic active ingredients, etc., can solve problems such as contradictory results and controversial clinical data of n-3PUFA

Pending Publication Date: 2018-11-09
SLA PHARMA AG
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  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0007] Despite experimental evidence for the biological plausibility of the role of n-3PUFA in inflammatory bowel disease (IBD), clinical data on the effectiveness of n-3PUFA in IBD are still controversial and conflicting, especially In Crohn's disease (CD)
10-12 Notably, recent epidemiological studies have shown that n-3PUFA can prevent the development of UC 13-15 , but the results are contradictory

Method used

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  • Highly purified eicosapentaenoic acid, as free fatty acid, reduces fecal calprotectin levels and prevents clinical relapse in ulcerative colitis patients
  • Highly purified eicosapentaenoic acid, as free fatty acid, reduces fecal calprotectin levels and prevents clinical relapse in ulcerative colitis patients
  • Highly purified eicosapentaenoic acid, as free fatty acid, reduces fecal calprotectin levels and prevents clinical relapse in ulcerative colitis patients

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Embodiment Construction

[0022] Prevention of clinical relapse represents a major outcome in the treatment of patients with ulcerative colitis (UC). High fecal calprotectin levels are indicative of mucosal inflammation and have been shown to predict clinical relapse in many groups of UC patients. Recent epidemiological studies have shown that n-3 polyunsaturated fatty acids prevent the development of UC. Eicosapentaenoic acid, a major component of n-3 fish oil, has been shown to have anti-inflammatory properties in chronic inflammatory conditions. The purpose of the present invention was to determine the effectiveness of highly purified eicosapentaenoic acid as a free fatty acid (EPA-FFA) in reducing fecal calprotectin levels and preventing relapse in a cohort of asymptomatic UC patients with Risk of clinical relapse, defined as fecal calprotectin levels ≥ 150 μg / g.

[0023] As shown herein, a placebo-controlled trial of 60 patients with UC treated by administration of highly pure EPA-FFA for 6 mont...

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Abstract

The present invention relates to a method of administering an effective dose of highly purified eicosapentaenoic acid as free-fatty acid (EPA-FFA) to reduce fecal calprotectin levels and reduce the risk of clinical relapse in UC patients. The eicosapentaenoic acid, in the free fatty acid (EPA-FFA) form, has a purity of at least 95%, and more preferably at least 99%.

Description

[0001] Cross References to Related Applications [0002] This application claims priority to U.S. Provisional Patent Application Serial No. 62 / 456,816, filed February 9, 2017, the contents of which are hereby incorporated by reference in their entirety. technical field [0003] The present invention relates to the use of highly purified eicosapentaenoic acid as a free fatty acid (EPA-FFA) for reducing fecal calprotectin levels and recurrence in subjects with ulcerative colitis. Background technique [0004] Ulcerative colitis (UC) is a chronic inflammatory condition affecting the colon that is characterized by alternating periods of activity and remission. 1 Clinical activity is often preceded by progressive asymptomatic mucosal inflammation. Effective treatment of preclinical conditions can prevent clinical relapse and can potentially play a pivotal role in the management of UC. [0005] Fecal calprotectin (FC) is a 36 kilodalton calcium and zinc binding protein that acco...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/557A61P1/00A61K45/06
CPCA61K45/06A61K31/557A61P1/00A61K31/202A61K31/606A61K31/573A61P1/04A61P29/00
Inventor 安德列·贝卢齐
Owner SLA PHARMA AG
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