Intercept Pharmaceuticals Announces Pivotal Phase 3 Clinical Trial of Obeticholic Acid in NASH
-Key features of the REGENERATE Phase 3 trial in non-cirrhotic NASH with liver fibrosis finalized pursuant to consultations with
-REGENERATE trial design intended to support initial approval on interim 72-week histology endpoint and full approval on liver-related outcomes endpoint
-Conference Call Scheduled
The REGENERATE trial will be conducted at approximately 250 centers in
The interim analysis after 72 weeks of treatment in approximately 1,400 patients will be conducted on the following co-primary endpoints, which are intended to serve as the basis for seeking U.S. and international marketing approvals: (i) the proportion of OCA-treated patients relative to placebo achieving at least one stage of liver fibrosis improvement with no worsening NASH; and (ii) the proportion of OCA-treated patients relative to placebo achieving NASH resolution with no worsening of liver fibrosis. Additional supportive histologic endpoints and non-invasive markers of liver fibrosis and steatohepatitis will also be evaluated. The REGENERATE trial will remain blinded after the interim analysis and continue to follow patients until the occurrence of a pre-specified number of adverse liver-related clinical events, including progression to cirrhosis, to confirm clinical benefit on a post-marketing basis.
"We are very pleased to announce the key aspects of our planned Phase 3 REGENERATE trial today, a culmination of our analyses of the FLINT trial results in OCA-treated NASH patients with advanced liver fibrosis and extensive collaboration with U.S. and European regulatory agencies," said
"Recently presented data analyses in patients with NASH and liver fibrosis from the FLINT trial suggest that in addition to OCA's apparent ability to resolve NASH, OCA appears to meaningfully improve liver fibrosis, particularly in those patients at higher risk of progressing to cirrhosis," said Vlad Ratziu, M.D., Ph.D., Professor of Hepatology at the
Conference Call on
Intercept will hold a conference call and webcast on
About Intercept
Intercept is a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat neglected chronic liver diseases. The company's lead product candidate, obeticholic acid (OCA), is an agonist of the farnesoid X receptor (FXR). OCA is being developed for a variety of chronic liver diseases, including primary biliary cirrhosis (PBC), nonalcoholic steatohepatitis (NASH), primary sclerosing cholangitis (PSC) and biliary atresia. The
Safe Harbor Statements
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the clinical, preclinical and regulatory developments for our product candidates, including the design and powering of the Phase 3 clinical trial of OCA in NASH with liver fibrosis, the anticipated results of our clinical and preclinical trials and other development activities and the timing thereof, our plans and ability to seek marketing approval for OCA in NASH with liver fibrosis on the basis of a pre-planned interim analysis, our potential development and regulatory milestones and the timeframes under which we anticipate such milestones may be achieved, including the anticipated initiation of the Phase 3 clinical trial of OCA in NASH with liver fibrosis, our plans in relation to other
subpopulations of patients with NASH, and our strategic directives under the caption "About Intercept." These "forward-looking statements" are based on management's current expectations of future events and are subject to a number of important risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: the initiation, cost, timing, progress and results of our development activities, preclinical studies and clinical trials; the timing of and our ability to obtain and maintain regulatory approval of OCA and any other product candidates we may develop, particularly the possibility that regulatory authorities may require clinical outcomes data (and not just results based on achievement of a surrogate endpoint) as a condition to
any marketing approval for OCA, and any related restrictions, limitations, and/or warnings in the label of any approved product candidates; our plans to research, develop and commercialize our product candidates; the election by our collaborators to pursue research, development and commercialization activities; our ability to attract collaborators with development, regulatory and commercialization expertise; our ability to obtain and maintain intellectual property protection for our product candidates; our ability to successfully commercialize our product candidates; the size and growth of the markets for our product candidates and our ability to serve those markets; the rate and degree of market acceptance of any future products; the success of competing drugs that are or become available; regulatory developments in
CONTACT: For more information about Intercept, please contactSource:Barbara Duncan orSenthil Sundaram , both ofIntercept Pharmaceuticals at 1-646-747-1000. Media inquiries: media@interceptpharma.com Investor inquiries: investors@interceptpharma.com
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