NEW YORK, Jan 29, 2020 (GLOBE NEWSWIRE via COMTEX) — NEW YORK, Jan. 29, 2020 (GLOBE NEWSWIRE) — Intercept Pharmaceuticals, Inc. ICPT, -1.01%, a biopharmaceutical aggregation focused on the development and commercialization of atypical analysis to amusement accelerating non-viral alarmist diseases, today appear that it has completed accommodating accepting in its Appearance 3 REVERSE abstraction evaluating obeticholic acerbic (OCA) for the analysis of compensated cirrhosis due to nonalcoholic steatohepatitis (NASH).
“NASH patients who advance cirrhosis accept a decidedly added accident of alarmist abortion and death,” said Mark Pruzanski, M.D., President and Chief Executive Officer of Intercept. “The accomplishment of accepting in REVERSE brings us one footfall afterpiece to bringing a much-needed analysis to the growing cardinal of bodies active with compensated cirrhosis due to this disease.”
The REVERSE abstraction is a randomized, double-blind, placebo-controlled, multicenter Appearance 3 abstraction evaluating the assurance and adeptness of OCA in NASH patients with compensated cirrhosis. The primary endpoint is the allotment of patients with histological advance in fibrosis by at atomic one date with no deepening of NASH application the NASH Analytic Analysis Network (CRN) scoring arrangement afterwards 18 months of treatment. Over 900 patients accept been randomized in a 1:1:1 arrangement to the three analysis arms: once-daily OCA 10 mg, once-daily OCA 10 mg for the aboriginal three months with titration in accordance with the abstraction agreement up to OCA 25 mg for the absolute abstraction period, or once-daily placebo. Patients who auspiciously complete the double-blind appearance of REVERSE will be acceptable to accept in an open-label addendum appearance for up to 12 added months.
About Alarmist Fibrosis and Cirrhosis due to Nonalcoholic Steatohepatitis (NASH)
Nonalcoholic steatohepatitis (NASH) is a austere accelerating alarmist ache acquired by boundless fat accession in the alarmist that induces abiding inflammation, consistent in accelerating fibrosis (scarring) that can advance to cirrhosis, closing alarmist failure, blight and death. There are currently no medications accustomed for the analysis of NASH.
Cirrhosis may aftereffect in decompensated alarmist ache associated with complications of ascites, variceal bleeding and hepatic encephalopathy. Alarmist abortion is believed to be the basic anniversary of anguish and bloodshed in patients with compensated cirrhosis due to NASH, and patients with cirrhosis are at 105 times greater accident of alarmist accompanying anguish compared to those after fibrosis. In addition, in the U.S. patients with cirrhosis are estimated to anniversary for added than 80 percent of anniversary absolute medical costs in NASH.
Intercept is a biopharmaceutical aggregation focused on the development and commercialization of atypical analysis to amusement accelerating non-viral alarmist diseases, including primary biliary cholangitis (PBC) and nonalcoholic steatohepatitis (NASH). Founded in 2002 in New York, Intercept has operations in the United States, Europe and Canada. For added information, amuse appointment www.interceptpharma.com or affix with the aggregation on Twitter and LinkedIn.
Cautionary Note Apropos Forward-Looking Statements
This columnist absolution contains advanced statements, including, but not bound to, statements apropos the progress, timing and after-effects of our analytic trials, including our analytic trials for the analysis of nonalcoholic steatohepatitis (“NASH”), the assurance and adeptness of our accustomed product, Ocaliva (obeticholic acerbic or “OCA”) for primary biliary cholangitis (“PBC”), and our artefact development candidates, including OCA for NASH, the timing and accepting of our authoritative filings and the abeyant approval of OCA for NASH or any added break in accession to PBC, the timing and abeyant bartering success of OCA and any added artefact candidates we may advance and our strategy, approaching operations, approaching banking position, approaching revenue, projected costs, banking guidance, prospects, plans, and objectives.
These statements aggregate advanced statements aural the acceptation of Section 27A of the Balance Act of 1933, as amended, and Section 21E of the Balance Exchange Act of 1934, as amended. The words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “will,” “would,” “could,” “should,” “possible,” “continue” and agnate expressions are advised to analyze advanced statements, although not all advanced statements accommodate these anecdotic words. Readers are cautioned not to abode disproportionate assurance on these advanced statements, which allege alone as of the date of this release, and we undertake no obligation to amend any advanced account except as appropriate by law. These advanced statements are based on estimates and assumptions by our administration that, although believed to be reasonable, are inherently ambiguous and accountable to a cardinal of risks. The afterward represent some, but not necessarily all, of the factors that could anniversary absolute after-effects to alter materially from actual after-effects or those advancing or predicted by our advanced statements: our adeptness to auspiciously commercialize Ocaliva for PBC; our adeptness to advance our authoritative approval of Ocaliva for PBC in the United States, Europe, Canada, Israel, Australia and added jurisdictions in which we accept or may accept business authorization; the initiation, timing, cost, conduct, advance and after-effects of our analysis and development activities, preclinical studies and analytic trials, including any issues, delays or failures in anecdotic patients, enrolling patients, alleviative patients, application patients, affair specific endpoints in the jurisdictions in which we intend to seek approval or commutual and appropriate advertisement the after-effects of our NASH or PBC analytic trials; our adeptness to appropriate and cost-effectively book for and access authoritative approval of our artefact candidates, including the authoritative approval of our New Drug Application for NASH; any advising board advocacy that our artefact candidates, including OCA for NASH, should not be accustomed or accustomed alone beneath assertive conditions; any assurance that the authoritative applications and consecutive advice we abide for our artefact candidates, including OCA for NASH, do not accommodate able analytic or added abstracts or accommodated applicative authoritative requirements for approval; altitude that may be imposed by authoritative authorities on our business approvals for our articles and artefact candidates, such as the charge for analytic outcomes abstracts (and not aloof after-effects based on accomplishment of a agent endpoint), and any accompanying restrictions, limitations and/or warnings independent in the characterization of any of our articles or artefact candidates; any abeyant ancillary furnishings associated with Ocaliva for PBC, OCA for NASH or our added artefact candidates that could adjournment or anticipate approval, crave that an accustomed artefact be taken off the market, crave the admittance of assurance warnings or precautions, or contrarily absolute the auction of such artefact or artefact candidate; our adeptness to authorize and advance relationships with, and the achievement of, third-party manufacturers, arrangement analysis organizations and added vendors aloft whom we are essentially abased for, amid added things, the accomplish and accumulation of our products, including Ocaliva for PBC and, if approved, OCA for NASH, and our analytic balloon activities; our adeptness to identify, advance and auspiciously commercialize our articles and artefact candidates, including our adeptness to appropriate and auspiciously barrage OCA for NASH, if approved; our adeptness to access and advance bookish acreage aegis for our articles and artefact candidates, including our adeptness to cost-effectively file, prosecute, avert and accomplish any apparent claims or added bookish acreage rights; the admeasurement and advance of the markets for our articles and artefact candidates and our adeptness to serve those markets; the amount of bazaar accepting of Ocaliva for PBC and, if approved, OCA for NASH or our added artefact candidates amid physicians, patients and healthcare payors; the availability of able advantage and agreement from authoritative and clandestine healthcare payors for our products, including Ocaliva for PBC and, if approved, OCA for NASH, and our adeptness to access able appraisement for such products; our adeptness to authorize and advance able sales, business and administration capabilities, either anon or through collaborations with third parties; antagonism from absolute drugs or new drugs that become available; our adeptness to anticipate arrangement failures, abstracts breaches or violations of abstracts aegis laws; costs and outcomes apropos to any disputes, authoritative inquiries or investigations, acknowledged affairs or litigation, including any securities, bookish property, employment, artefact accountability or added litigation; our collaborators’ acclamation to accompany research, development and commercialization activities; our adeptness to authorize and advance relationships with collaborators with development, authoritative and commercialization expertise; our charge for and adeptness to accomplish or access added financing; our estimates apropos approaching expenses, revenues and basic requirements and the accurateness thereof; our use of banknote and concise investments; our adeptness to acquire, authorization and advance in businesses, technologies, artefact candidates and products; our adeptness to allure and absorb key cadre to administer our business effectively; our adeptness to administer the advance of our operations, infrastructure, personnel, systems and controls; our adeptness to access and advance able allowance coverage; the appulse of accepted U.S. and adopted economic, industry, market, authoritative or political conditions, including the abeyant appulse of Brexit; and the added risks and uncertainties articular in our alternate filings filed with the U.S. Balance and Exchange Commission, including our Anniversary Report on Form 10-K for the year concluded December 31, 2018.
For added advice about Intercept, amuse contact:
Lisa DeFrancesco 1-646-565-4833 [email protected]
Christopher Frates 1-646-757-2371 [email protected]
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