Navigation Links
Catabasis Initiates Phase 1 Trial of CAT-2003 for Treatment of Severe Hypertriglyceridemia
Date:3/26/2013

CAMBRIDGE, Mass., March 26, 2013 /PRNewswire/ -- Catabasis Pharmaceuticals Inc., today announced the initiation of a Phase 1 study to investigate the safety and tolerability of CAT-2003 in healthy volunteers and in adults with mildly elevated lipids. CAT-2003 is a conjugate of niacin and eicosapentaenoic acid (EPA), an omega-3 fatty acid, covalently linked using the company's proprietary SMART Linker technology to create a new chemical entity and is being developed for patients with severe hypertriglyceridemia.

"Advancing CAT-2003 into the clinic is another important milestone for Catabasis after recently announcing positive Phase 1 data for CAT-1004 that validated our SMART Linker platform," said Michael Jirousek , Ph.D., chief scientific officer of Catabasis. "In preclinical animal models, CAT-2003 produced robust triglyceride and low density lipoprotein (LDL) cholesterol lowering, and synergistic reductions in LDL cholesterol when CAT-2003 was combined with a statin."

This randomized, double-blind, placebo-controlled Phase 1 study will be conducted in two parts. In the first part, healthy adults will receive a single ascending dose of CAT-2003 or placebo. In the second part, healthy adults or patients with mildly elevated lipids will receive CAT-2003 or placebo daily for 14 days. The study will evaluate safety, tolerability and pharmacokinetics.  Triglycerides, LDL cholesterol and biomarkers related to the mechanism of action of CAT-2003 will also be assessed. Data is expected in the second quarter of 2013.

For more information on this trial see clinicaltrials.gov.

About CAT-2003CAT-2003 is a new chemical entity that is a conjugate of the B vitamin niacin and eicosapentaenoic acid (EPA), an omega-3 fatty acid, linked using the company's proprietary SMART Linker technology. It is being investigated for the treatment of severe hypertriglyceridemia. In preclinical models of severe hypertriglyceridemia, a significant and dose-dependent reduction in plasma triglycerides was observed with CAT-2003, while a simple combination of niacin and omega-3 had only a marginal effect. In preclinical models of dyslipidemia, CAT-2003 dramatically reduced LDL cholesterol.  In combination with a statin, CAT-2003 synergistically lowered LDL cholesterol.  Because CAT-2003 is not activated until it is delivered to the target cell, CAT-2003 is not expected to activate the receptor that causes "niacin flush," a side effect characterized by blushing of the skin and a sensation of warmth resulting from blood vessel dilation; this effect can reduce patient compliance.

About HypertriglyceridemiaSevere hypertriglyceridemia refers to a condition involving levels of triglycerides equal to or above 500 mg/dL. Severe hypertriglyceridemia is associated with markedly increased risk for cardiovascular disease and pancreatitis, and recent studies have demonstrated that elevated triglyceride levels can be regarded as an independent risk factor for cardiovascular events such as myocardial infarction, ischemic heart disease and ischemic stroke.  The prevalence of hypertriglyceridemia is rapidly increasing in the United States and throughout the world.  It is estimated that over four million patients have severe hypertriglyceridemia in the United States. The National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation and Treatment of High Blood Cholesterol recommends that the first priority for the management of severe hypertriglyceridemia be triglyceride reduction to decrease the risk of pancreatitis. Current treatments include adhering to a low-fat, low-carbohydrate diet, exercise and alcohol abstinence. Medical therapies can include statins to normalize other lipid parameters, fibrates and omega-3 fatty acids.

About CatabasisCatabasis is a clinical-stage company dedicated to the discovery and development of innovative, effective and safe medicines to treat inflammatory and metabolic diseases. The company's drug development programs are rooted in the principles of pathway pharmacology, the treatment of diseases by simultaneously modulating more than one target in a disease pathway. Using its proprietary SMART Linker technology, the company conjugates two drugs that act on different components of a disease pathway to produce new chemical entities with significantly enhanced efficacy and an improved safety and tolerability profile. The company has assembled a team of passionate and experienced scientists who are committed to improving the lives of patients. The company was founded in 2008 and is headquartered in Cambridge, Mass.

Please visit www.catabasis.com for more information.Media ContactsCorporate ContactTony Russo, Ph.D.Amy LynchMatt Middleman, M.D.Catabasis Pharmaceuticals, Inc.Russo Partners T: (617)-349-1971T: 212-845-425alynch@catabasis.comT: 212-845-4272tony.russo@russopartnersllc.commatt.middleman@russopartnersllc.com
'/>"/>

SOURCE Catabasis Pharmaceuticals Inc.
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Alliqua Initiates Life-Cycle Management Plan to Expand Wound Care Portfolio for Use in Broader Wound Indications
2. Lithera Initiates Phase 2b Clinical Trial of LIPO-202 Targeting Aesthetic Reduction of Subcutaneous Abdominal Fat
3. Isis Pharmaceuticals Initiates Phase 2 Study Of ISIS-CRP Rx In Patients With Atrial Fibrillation
4. NxStage Initiates 2013 Call to Action Campaign with Launch of Hemodialysis At Home: A Better Way For a Better Life
5. Coyote Pharmaceuticals Initiates GMP Manufacturing Process for CNS-102 Following Successful Pre-IND Meeting
6. Nanomix Initiates Clinical Testing of Point of Care IVD Cardiac Panel
7. ADVENTRX Initiates Pivotal Phase 3 Study of ANX-188
8. uniQure Initiates Phase I in Acute Intermittent Porphyria
9. Fate Therapeutics Initiates Phase 2 Clinical Study of ProHema for the Treatment of Hematologic Malignancies
10. The Acute Liver Failure Study Group Initiates Phase 2a Study of OCR-002 for Treatment of Acute Liver Failure after Acetaminophen Overdose
11. Isis Pharmaceuticals Initiates Phase 1b/2a Study Of ISIS-SMNRx In Patients With Spinal Muscular Atrophy
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/5/2016)... , Feb. 5, 2016  Henry Schein, Inc. (NASDAQ: ... products and services to office-based dental, animal health and ... an agreement to acquire a majority ownership interest in ... equipment in Brazil . ... Blumenau, Brazil, Dental Cremer is the dental distribution business of ...
(Date:2/5/2016)... 4, 2016 France , ... , UK, and Israel ). It includes a 10-year ... 3 GD, segmented by age and sex in these markets. GD epidemiology ... Report is in-depth, high quality, transparent and market-driven, providing expert analysis of ... Germany , Italy , ...
(Date:2/4/2016)... For hospitals considering enrollment in the Federal ... the program, the Health Resources and Services Administration,s (HRSA) ... Mega-Guidance , could have significant impact on plans and ... 2016. Essential Insights , Daniel Neal, ... the Mega-Guidance,s key proposed changes, including a new requirement ...
Breaking Medicine Technology:
(Date:2/5/2016)... & Salt Lake City, UT (PRWEB) , ... February 05, 2016 ... ... of Activz Whole-Food Nutrition , announced that the much-anticipated feature with author Jahnavi ... New Really Cool Humans Amateur TV Network. , Each week, on his weekly Whole-Food ...
(Date:2/5/2016)... (PRWEB) , ... February 05, 2016 , ... Looking for ... may be at the tips of your toes. Foot massage, whether administered by a ... pure comfort and relaxation. The American Board of Multiple Specialties in Podiatry ...
(Date:2/5/2016)... ... February 05, 2016 , ... In ... across the country gathered at the La Valencia Hotel in San Diego, California ... Chicago was named the year’s most outstanding franchise, walking away with the coveted ...
(Date:2/5/2016)... ... February 05, 2016 , ... Pivot Point Consulting, a leading ... Software & Services for HIT Implementation Support & Staffing report with an outstanding ... performance by healthcare executives, managers and clinicians representing over 4,500 hospitals and 2,500 ...
(Date:2/5/2016)... , ... February 05, 2016 , ... Colorize ... on one drop zone to the next using Colorize's dynamic moving camera. Colorize is ... This package includes a 3D slideshow environment with 1 to 5 focus points per ...
Breaking Medicine News(10 mins):