Navigation Links
Initiation of FLINT Announced by NIDDK: Study of Intercept Pharmaceuticals' Obeticholic Acid (INT-747) in NASH

NEW YORK, March 29, 2011 /PRNewswire/ -- Intercept Pharmaceuticals, Inc., has been informed by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the National Institutes of Health that patient enrollment has started in a new clinical trial in patients with nonalcoholic steatohepatitis (NASH), which will evaluate Intercept's first-in-class farnesoid X receptor (FXR) agonist obeticholic acid (OCA) as a novel therapy for NASH. The FXR Ligand NASH Treatment (FLINT) trial is a double blind, placebo controlled, multi-center clinical study that will evaluate the effects of OCA compared with placebo in adult NASH patients.

NASH is a more serious form of nonalcoholic fatty liver disease (NAFLD) and occurs in patients who drink little or no alcohol. The disease is believed to be caused by abnormal metabolism of fats and, although it is often associated with obesity and insulin resistance, it also occurs in lean individuals. NASH is associated with fibrosis (scarring) in the liver that may lead to cirrhosis, liver cancer and death, and the disease also carries an additional mortality risk due to heart disease. NASH is now the most common liver disease in the developed world, affecting at least 3-5% of the U.S. population and up to 50% of patients with morbid obesity.  There is currently no approved treatment for the disease.

FLINT will enroll 280 patients at the eight U.S. centers comprising the NIDDK-sponsored NASH Clinical Research Network.  The primary endpoint in the 72 week study will be determined by liver biopsy and is defined as an improvement in the NAFLD activity score with no worsening of liver fibrosis.  NIDDK is providing the majority of funding for the study and is partnering with Intercept under a cooperative research and development agreement (CRADA).

"It is a privilege to be collaborating with this group of leading NASH investigators and the NIDDK," commented David Shapiro, MD, Chief Medical Officer of Intercept. "FLINT has been carefully designed to evaluate the efficacy of OCA in NASH patients and we believe it will be the largest clinical trial conducted to date in this large untreated patient population."

"Past clinical trials of marketed drugs in NASH have been disappointing and an effective therapy is urgently needed," added Mark Pruzanski, MD, Intercept's founder and CEO. "We believe that OCA's mechanism of action as an FXR agonist makes it a very promising candidate and we are excited that the FLINT study has started enrolling patients."

See for additional information about FLINT.

About Obeticholic Acid (OCA or INT-747)

OCA is a potent, first-in-class farnesoid X receptor (FXR) agonist derived from the primary human bile acid chenodeoxycholic acid, the natural endogenous FXR agonist.  Intercept has announced positive Phase II results from randomized clinical trials in type 2 diabetics with NAFLD and in patients with primary biliary cirrhosis (PBC), the most common autoimmune liver disease.  These clinical data and OCA's mechanism of action support its potential as a novel, hepatoprotective agent in a broad range of chronic liver diseases. Intercept is currently preparing for the initiation of a Phase III PBC program in the U.S. and Europe, while pursuing additional studies in other indications such as NASH and portal hypertension.  

About Intercept Pharmaceuticals

Intercept is a biopharmaceutical company focused on discovering and developing small molecule drugs for the treatment of chronic liver and metabolic diseases.  The company's most advanced programs are focused on the development of modified bile acids that are selective for FXR, a nuclear receptor, and TGR5, a G protein-coupled receptor. Bile acid signaling through these receptors regulates key aspects of lipid, glucose and overall energy metabolism, while also serving to maintain the functional integrity of the liver, intestine and kidneys, organs that are exposed to bile acid flux.

For more information about Intercept, please go to CONTACT: Mark Pruzanski, M.D. or Barbara Duncan, both of Intercept, +1-646-747-1000. For information about Intercept's majority shareholder Genextra S.p.A., please go to

SOURCE Intercept Pharmaceuticals, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Vion Pharmaceuticals Announces Initiation of a Phase I/II Trial of Cloretazine(R) (VNP40101M) in Combination with Temodar(R) in Adult Brain Tumors
2. Pharmacopeia Earns Milestone Payment From Schering-Plough on Initiation of Phase 1 Clinical Trials of Novel Therapeutic Candidate
3. Nastech Pharmaceutical Company Announces Initiation of Phase 2 Clinical Trial for Insulin Nasal Spray to Treat Diabetes
4. Nastech Pharmaceutical Company Announces Initiation of Phase 2 Clinical Trial for PYY3-36 Nasal Spray to Treat Obesity
5. Isis Earns $5 Million Milestone Payment From Ortho-McNeil, Inc. for Initiation of Phase 1 Study of ISIS 325568
6. Palatin Technologies, Inc. Reports Initiation of Human Trials for the Treatment of Congestive Heart Failure
7. Epiphany Biosciences Reports Initiation and Enrollment in Valomaciclovir Study for Shingles
8. Retrospective Analysis Finds That Initiation of Insulin Glargine in Patients With Type 2 Diabetes was Associated With a Lower Incidence Rate of Myocardial Infarction as Compared With NPH Insulin
9. Synvista Therapeutics Announces Initiation of Phase 2 Study With Alagebrium for Chronic Heart Failure
10. Vion Pharmaceuticals Announces Initiation of Clinical Trial of Cloretazine(R) (VNP40101M) in Combination with Stem Cell Transplantation
11. Rigel Announces Initiation of Phase 1 Clinical Trial of R343 for Allergic Asthma by its Partner Pfizer
Post Your Comments:
(Date:6/26/2016)... Ontario , June 27, 2016  VMS Rehab ... Company,s Board will take whatever measures required to build ... Company,s stock which is currently listed on the OTC ... Wexler, Company Chairman and CEO, "We are seeing an ... difficult to understand, not only by the Company, but ...
(Date:6/24/2016)... N.J. , June 24, 2016  Collagen ... the design, development and manufacturing of collagen and ... regeneration announced today that Bill Messer ... and Marketing to further leverage the growing portfolio ... medical devices. Bill joins the Collagen ...
(Date:6/24/2016)... 24, 2016 ... the addition of the " Global Markets for ... This report focuses on ... updated review, including its applications in various applications. The ... which includes three main industries: pharmaceutical and biotechnology, food ...
Breaking Medicine Technology:
(Date:6/25/2016)... ... ... closing of Bruton Memorial Library on June 21 due to a possible lice infestation, as ... of head lice: the parasite’s ability to live away from a human host, and to ... one in the event that lice have simply gotten out of control. , As lice ...
(Date:6/25/2016)... Oklahoma City, Oklahoma (PRWEB) , ... June 25, ... ... to helping both athletes and non-athletes recover from injury. Recently, he has implemented ... for the Oklahoma City area —Johnson is one of the first doctors to ...
(Date:6/24/2016)... ... June 24, 2016 , ... Those who have experienced traumatic ... many turn to unhealthy avenues, such as drug or alcohol abuse, as a coping ... released tools for healthy coping following a traumatic event. , Trauma sufferers tend to ...
(Date:6/24/2016)... ... June 24, 2016 , ... Global law firm Greenberg ... Legal Elite. The attorneys chosen by their peers for this recognition are considered among ... Greenberg Traurig Shareholders received special honors as members of this year’s Legal Elite Hall ...
(Date:6/24/2016)... ... 2016 , ... People across the U.S. are sharpening their pencils and honing ... contest in which patients and their families pay tribute to a genetic counselor by ... Society of Genetic Counselors (NSGC) Annual Education Conference (AEC) this September. , In ...
Breaking Medicine News(10 mins):