Intercept Pharmaceuticals, Inc. (Nasdaq:ICPT), a biopharmaceutical
company focused on the development and commercialization of novel
therapeutics to treat progressive non-viral liver diseases, today
announced that multiple obeticholic acid (OCA) abstracts will be
presented at The Liver Meeting® 2017, the Annual Meeting of the
American Association for the Study of Liver Diseases (AASLD),
taking place October 20-24 in Washington, D.C. Among the highlights
is a late breaking oral presentation of results from the Phase 2
AESOP trial evaluating OCA for the treatment of patients with
primary sclerosing cholangitis (PSC).
“Our data at this year’s Liver Meeting add to the large body of
evidence supporting the use of Ocaliva to treat PBC, and underscore
Intercept’s ongoing commitment to advancing the clinical
development of OCA in other progressive, non-viral liver diseases
with high unmet need,” said David Shapiro, M.D., Chief Medical
Officer of Intercept. “In addition to new research in PBC and NASH,
we are looking forward to the first presentation of results from
our Phase 2 trial of OCA in PSC, a devastating cholestatic liver
disease for which there are currently no approved treatment
options.”
Intercept will be exhibiting at booths 533 and 242 throughout
the meeting. Select presentations at The Liver Meeting include:
Late-Breaking Oral Presentation:
Monday, October 23, 2017 – 2:30-4:30 p.m. ET
“The AESOP Trial: A Randomized, Double-Blind,
Placebo-Controlled, Phase 2 Study of Obeticholic Acid in Patients
with Primary Sclerosing Cholangitis”Kris V. Kowdley,
Christopher L. Bowlus, Cynthia Levy, Raj Vuppalanchi, Annarosa
Floreani, Pietro Andreone, Nicholas F. LaRusso, Roshan Shrestha,
James Trotter, David S. Goldberg, Simon Rushbrook, Gideon M.
Hirschfield, Courtney Van Biene, Richard Pencek, Leigh MacConell,
David Shapiro
Poster Presentations:
Friday, October 20, 2017 – 8 a.m. – 5:30 p.m. ET
“Unmet Need of Patients with Primary Biliary Cholangitis
(PBC) Based on Alkaline Phosphatase (ALP) Threshold Using Large
Database with Electronic Medical Records (EMRs) and Claims Data: A
Cross-sectional Analysis” (Abstract #277)Zobair M.
Younossi, Robert S. Epstein, Marcie Strauss, Shailja Dixit
“Development of a Dose Regiment for Obeticholic Acid in
Patients with Primary Biliary Cholangitis and Hepatic Impairment”
(Abstract #296)Jeffrey Edwards, Carl LaCerte, Thomas
Peyret, Nathalie H. Gosselin, J.F. Marier
“Efficacy of Obeticholic Acid Treatment Through 24
Months of Open-Label Extension in Patients with Primary Biliary
Cholangitis and Cirrhosis: Data From POISE” (Abstract
#306)John M. Vierling, Gideon M. Hirschfield, David Jones,
Roberto J. Groszmann, Kris V. Kowdley, Richard Pencek, Elizabeth
Smoot Malecha, Leigh MacConell
“Reductions in Abnormal Direct Bilirubin with
Obeticholic Acid in Patients with Primary Biliary Cholangitis”
(Abstract #307)Albert Pares, Victor Vargas, Mitchell L.
Shiffman, Gideon M. Hirschfield, Pietro Invernizzi, Alexander
Liberman, Elizabeth Smoot Malecha, Janet Owens-Grillo, Juan C.
Lopez-Talavera
A full list of sessions at The Liver Meeting, including
symposia, is available on the AASLD website.
About Primary Biliary Cholangitis
Primary biliary cholangitis (PBC) is a rare, autoimmune
cholestatic liver disease that puts patients at risk for
life-threatening complications. PBC is primarily a disease of
women, afflicting approximately one in 1,000 women over the age of
40. If left untreated, survival of PBC patients is significantly
worse than the general population.
About Nonalcoholic Steatohepatitis
Nonalcoholic steatohepatitis (NASH) is a serious progressive
liver disease caused by excessive fat accumulation in the liver
that induces chronic inflammation, resulting in progressive
fibrosis (scarring) that can lead to cirrhosis, eventual liver
failure, cancer and death. There are currently no medications
approved for the treatment of NASH. The proportion of liver
transplants attributable to NASH has increased rapidly in past
years and by 2020 the disease is projected to become the leading
indication for liver transplant.
About Primary Sclerosing Cholangitis
Primary sclerosing cholangitis (PSC) is a rare,
life-threatening, chronic cholestatic liver disease characterized
by progressive destruction of bile ducts that leads to the
development of cirrhosis and end-stage liver disease or cancer in a
majority of patients. There are no approved therapies for PSC,
and estimated survival time from PSC diagnosis to death or liver
transplant is 14.5 years. Approximately 65% of PSC patients are
male, and 60%-80% of patients have concomitant inflammatory bowel
disease (IBD), most often ulcerative colitis. Although it is a
rare disease, PSC is the seventh leading indication for liver
transplant in adults in the United States.
About Ocaliva® (obeticholic acid)
Ocaliva is indicated in the United States for the treatment of
primary biliary cholangitis (PBC) in combination with
ursodeoxycholic acid (UDCA) in adults with an inadequate response
to UDCA, or as monotherapy in adults unable to tolerate UDCA.
This indication is approved under accelerated approval based on
a reduction in alkaline phosphatase (ALP), as a surrogate endpoint
which is reasonably likely to predict clinical benefit, including
an improvement in liver transplant free-survival. An improvement in
survival or disease-related symptoms has not been established.
Continued approval for this indication may be contingent upon
verification and description of clinical benefit in confirmatory
trials. Intercept is currently enrolling COBALT, a Phase 4 clinical
outcomes trial of Ocaliva in patients with PBC with the goal of
confirming clinical benefit on a post-marketing basis.
In December 2016, Ocaliva received conditional marketing
authorization in Europe for the treatment of PBC in combination
with UDCA in adults with an inadequate response to UDCA or as
monotherapy in adults unable to tolerate UDCA, conditional to the
company providing further data post-approval to confirm benefit.
Ocaliva received conditional approval from Health Canada in May
2017.
U.S. IMPORTANT SAFETY INFORMATION
Contraindications Ocaliva is contraindicated in
patients with complete biliary obstruction.
Warnings and Precautions
Liver-Related Adverse Reactions In two 3-month,
placebo-controlled clinical trials a dose-response relationship was
observed for the occurrence of liver-related adverse reactions
including jaundice, ascites and primary biliary cholangitis flare
with dosages of Ocaliva of 10 mg once daily to 50 mg once daily (up
to 5-times the highest recommended dosage), as early as one month
after starting treatment with Ocaliva.
In a pooled analysis of three placebo-controlled trials in
patients with PBC, the exposure-adjusted incidence rates for all
serious and otherwise clinically significant liver-related adverse
reactions, and isolated elevations in liver biochemical tests, per
100 patient exposure years (PEY) were: 5.2 in the Ocaliva 10 mg
group (highest recommended dosage), 19.8 in the Ocaliva 25 mg group
(2.5 times the highest recommended dosage) and 54.5 in the Ocaliva
50 mg group (5 times the highest recommended dosage) compared to
2.4 in the placebo group.
Monitor patients during treatment with Ocaliva for elevations in
liver biochemical tests and for the development of liver-related
adverse reactions. Weigh the potential risks against the benefits
of continuing treatment with Ocaliva in patients who have
experienced clinically significant liver-related adverse reactions.
The maximum recommended dosage of Ocaliva is 10 mg once daily.
Adjust the dosage for patients with moderate or severe hepatic
impairment.
Discontinue Ocaliva in patients who develop complete biliary
obstruction.
Severe Pruritus
Severe pruritus was reported in 23% of patients in the Ocaliva
10 mg arm, 19% of patients in the Ocaliva titration arm and 7% of
patients in the placebo arm in the POISE trial, a 12-month double-
blind randomized controlled trial of 216 patients. Severe pruritus
was defined as intense or widespread itching, interfering with
activities of daily living, or causing severe sleep disturbance, or
intolerable discomfort, and typically requiring medical
interventions. In the subgroup of patients in the Ocaliva titration
arm who increased their dosage from 5 mg once daily to 10 mg once
daily after 6 months of treatment (n=33), the incidence of severe
pruritus was 0% from months 0 to 6 and 15% from months 6 to 12. The
median time to onset of severe pruritus was 11, 158 and 75 days for
patients in the Ocaliva 10 mg, Ocaliva titration and placebo arms,
respectively.
Management strategies include the addition of bile acid resins
or antihistamines, Ocaliva dosage reduction and/or temporary
interruption of Ocaliva dosing.
Reduction in HDL-C
Patients with PBC generally exhibit hyperlipidemia characterized
by a significant elevation in total cholesterol primarily due to
increased levels of high density lipoprotein-cholesterol (HDLC). In
the POISE trial, dose-dependent reductions from baseline in mean
HDL-C levels were observed at 2 weeks in Ocaliva-treated patients,
20% and 9% in the 10 mg and titration arms, respectively, compared
to 2% in the placebo arm. At month 12, the reduction from baseline
in mean HDL-C level was 19% in the Ocaliva 10 mg arm, 12% in the
Ocaliva titration arm and 2% in the placebo arm. Nine patients in
the Ocaliva 10 mg arm and six patients in the Ocaliva titration
arm, versus three patients in the placebo arm had reductions in
HDL-C to less than 40 mg/dL.
Monitor patients for changes in serum lipid levels during
treatment. For patients who do not respond to Ocaliva after one
year at the highest recommended dosage that can be tolerated
(maximum of 10 mg once daily), and who experience a reduction in
HDL-C, weigh the potential risks against the benefits of continuing
treatment.
Adverse Reactions
The most common adverse reactions from subjects taking Ocaliva
(≥5%) were pruritus, fatigue, abdominal pain and discomfort, rash,
oropharyngeal pain, dizziness, constipation, arthralgia, thyroid
function abnormality and eczema.
Drug Interaction Bile Acid Binding Resins Bile
acid binding resins such as cholestyramine, colestipol or
colesevelam absorb and reduce bile acid absorption and may reduce
the absorption, systemic exposure and efficacy of Ocaliva. If
taking bile acid binding resins, take Ocaliva at least 4 hours
before or 4 hours after (or at as great an interval as possible)
taking a bile acid binding resin.
Please see the U.S. Full Prescribing Information for
Ocaliva (obeticholic acid) 5 mg and 10 mg tablets.
About Intercept
Intercept is a biopharmaceutical company focused on the
development and commercialization of novel therapeutics to treat
progressive non-viral liver diseases, including primary biliary
cholangitis (PBC), nonalcoholic steatohepatitis (NASH), primary
sclerosing cholangitis (PSC) and biliary atresia. Founded in 2002
in New York, Intercept now has operations in the United States,
Europe and Canada. For more information, please visit
www.interceptpharma.com or connect with the company on Twitter and
LinkedIn.
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, regarding the potential of OCA
to treat patients with PSC 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
potential benefit and commercial potential of Ocaliva in PBC, and
Intercept's ability to maintain its regulatory approval in
jurisdictions in which Ocaliva is approved for use in PBC; the
initiation, cost, timing, progress and results of Intercept's
development activities, preclinical studies and clinical trials;
the timing of and Intercept's ability to obtain and maintain
regulatory approval of OCA in PBC in countries outside the ones in
which it is approved and in indications other than PBC and any
other product candidates it may develop such as INT-767; conditions
that may be imposed by regulatory authorities on Intercept's
marketing approvals for its products and product candidates such as
the need for clinical outcomes data (and not just results based on
achievement of a surrogate endpoint), and any related restrictions,
limitations, and/or warnings in the label of any approved products
and product candidates; Intercept's plans to research, develop and
commercialize its product candidates; Intercept's ability to obtain
and maintain intellectual property protection for its products and
product candidates; Intercept's ability to successfully
commercialize its products and product candidates; the size and
growth of the markets for Intercept's products and product
candidates and its ability to serve those markets; the rate and
degree of market acceptance of any of Intercept's products, which
may be affected by the reimbursement received from payors; the
success of competing drugs that are or become available; regulatory
developments in the United States and other countries; the
performance of third-party suppliers and manufacturers; the
election by Intercept's collaborators to pursue research,
development and commercialization activities; Intercept's ability
to attract collaborators with development, regulatory and
commercialization expertise; Intercept's need for and ability to
obtain additional financing; Intercept's estimates regarding
expenses, revenues and capital requirements and the accuracy
thereof; Intercept's use of cash and short-term investments;
Intercept's ability to attract and retain key scientific or
management personnel; and other factors discussed under the heading
"Risk Factors" contained in our annual report on Form 10-K for the
year ended December 31, 2016 filed on March 1, 2017 as well as any
updates to these risk factors filed from time to time in our other
filings with the Securities and Exchange Commission. All
information in this press release is as of the date of the release,
and Intercept undertakes no duty to update this information unless
required by law.
Contact
For more information about Intercept Pharmaceuticals, please
contact:
Mark Vignola+1-646-747-1000investors@interceptpharma.com
Christopher Frates+1-646-757-2371media@interceptpharma.com
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