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POISE: Phase 3 Trial in Primary Biliary Cirrhosis

Double-Blind Phase Completed with Strong Enrollment into Long-Term Safety Extension Phase

POISE is a double-blind, placebo-controlled Phase 3 trial evaluating the safety and efficacy of a once daily dose of OCA in PBC patients with an inadequate therapeutic response to, or who are unable to tolerate, ursodiol. In December 2013, the last patient follow-up visit was completed, marking the conclusion of the double-blind phase of the POISE trial. Of the 217 patients randomized, 19 patients (approximately 9%) discontinued early, including seven patients (approximately 3%) who did so due to pruritus. Top-line results from the double-blind phase of the POISE trial are expected to be available in the second quarter of 2014.

Patients completing the double-blind phase have had the option to continue in an open-label, long-term safety extension (LTSE) phase for another five years, during which all patients will receive OCA treatment with daily doses starting at 5 mg and potentially titrating up to 25 mg a day, as clinically indicated. Of the 198 patients who completed the double-blind phase, more than 95% continued in the LTSE phase of the trial.
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Source: press release, 1/09/14. http://ir.interceptpharma.com/releasedetail.cfm?ReleaseID=818400

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POISE - A Phase 3, Double Blind, Placebo Controlled Trial and Long Term Safety Extension of Obeticholic Acid in Patients With Primary Biliary Cirrhosis
Estimated Enrollment: 180
Study Start Date: January 2012
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
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Source: clinical trials.gov. http://clinicaltrials.gov/ct2/show/NCT01473524?term=Obeticholic+Acid&ran...

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Compound/DeviceSpecialtyIndicationCompound ClassTarget
Obeticholic acid (OCA) PBCGastroenterologyPrimary Biliary Cirrhosis (PBC)Farnesoid X Receptor (FXR) AgonistFarnesoid X Receptor (FXR)

Mechanism of action: Obeticholic acid (OCA) is a bile acid analog and first-in-class Farnesoid X Receptor (FXR) agonist derived from the primary human bile acid chenodeoxycholic acid, or CDCA.

Phase of Development: III

Event Type: Data: Phase III trial results

Dates: 2014-04-01 - 2014-06-30

Results:

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Intercept Presents New Data at AASLD Examining the Effects of Ocaliva® (Obeticholic Acid) on Non-Invasive Assessments of Liver Fibrosis in Patients with PBC

Poster presentations explore changes in biochemical markers of disease progression in PBC patients with cirrhosis and renal impairment

NEW YORK, Nov. 11, 2016 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc. (Nasdaq:ICPT) (Intercept), a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat progressive non-viral liver diseases, today announced results from three new exploratory analyses of the Phase 3 POISE trial of Ocaliva® (obeticholic acid) in patients with primary biliary cholangitis (PBC). The analyses will be presented at the American Academy for the Study of Liver Diseases (AASLD) Annual Meeting (The Liver Meeting®), taking place in Boston, MA from November 11-15.

The POISE trial evaluated the safety and efficacy of once-daily treatment with Ocaliva in PBC patients with an inadequate therapeutic response to, or who are unable to tolerate, ursodeoxycholic acid (UDCA). Of 216 patients randomized to three treatment arms—placebo, Ocaliva 5 mg titrated to 10 mg or Ocaliva 10 mg—93% continued receiving UDCA.

The first POISE presentation (abstract #209) evaluated the effects of Ocaliva on non-invasive assessments of liver fibrosis using both transient elastography (Fibroscan™) and the AST to Platelet Ratio (APRI). These tests have been shown to be effective in predicting clinical outcomes in PBC, and Ocaliva-treated patients experienced improvements in both compared with those receiving placebo. In patients with transient elastography assessments at baseline and month 12 (approximately 43% of the study population), only Ocaliva-treated patients experienced a reduction in liver stiffness below 16.9 kPa, a threshold associated with the presence of cirrhosis. Mean liver stiffness reduction was observed in the 10 mg Ocaliva group compared to placebo. In patients with a baseline APRI score above 0.54 (a threshold associated with increased risk of adverse clinical outcomes in PBC patients), 35% of Ocaliva-treated patients compared to 13% of placebo-treated patients experienced an improvement to below 0.54 at the end of the 12 month double-blind phase.

"Because liver biopsies are not routinely used for staging patients with PBC, it is important that we explore non-invasive strategies to evaluate the effects of new therapies like Ocaliva on liver fibrosis," said Gideon Hirschfield, M.D., Professor and Honorary Consultant Hepatologist, Centre for Liver Research at the University of Birmingham, UK, who presented the data. "These results are very promising, and the ongoing Phase 4 COBALT trial of Ocaliva will provide us with a more definitive understanding of the drug's ability to improve non-invasive measures of liver fibrosis and reduce the risk of clinical outcomes in our patients with PBC."

The second POISE presentation (abstract #366) evaluated the efficacy and safety of Ocaliva in the subset (17%) of patients with cirrhosis who were at the greatest risk of progression to liver-related adverse outcomes or death. At month 12, more Ocaliva-treated patients with cirrhosis achieved the primary composite study endpoint compared to placebo. Ocaliva treatment improved markers of both cholestasis (alkaline phosphatase) and hepatic impairment (bilirubin) relative to placebo in patients with cirrhosis. Consistent with previous study results, pruritus (itch) was the most common adverse event associated with Ocaliva treatment. Additional side effects observed during the trial included fatigue, abdominal pain and discomfort, rash, oropharyngeal pain, dizziness, constipation, arthralgia, thyroid function abnormality, and eczema.

"This exploratory analysis suggests that high-risk PBC patients with compensated cirrhosis benefited from treatment with Ocaliva, and the results were comparable to what we observed in earlier stage non-cirrhotic patients," said John Vierling, M.D., F.A.C.P., F.A.A.S.L.D., Professor of Medicine and Surgery at Baylor College of Medicine, Past President of AASLD, and lead author of the abstract. "The bilirubin improvements in these patients are particularly meaningful because increasing bilirubin levels — even within the normal range — are one of the hallmarks of progressive disease and strongly associated with clinical outcomes."

The third POISE presentation (abstract #401) examined the effects of Ocaliva in PBC patients with mild and moderate renal impairment. In this exploratory analysis, Ocaliva demonstrated comparable efficacy regardless of renal status and enabled patients with renal impairment to achieve significant improvements in markers of cholestasis and hepatic damage. Ocaliva had no apparent effect on renal safety, with mild to moderate pruritus the most commonly occurring adverse event in all renal function groups.
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Source: press release, 11/11/16. http://ir.interceptpharma.com/releasedetail.cfm?ReleaseID=998990

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New Analyses of the Phase 3 POISE Trial of Ocaliva™ (Obeticholic Acid) for the Treatment of PBC Presented at EASL

NEW YORK, April 14, 2016 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc. (Nasdaq:ICPT), a clinical stage biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat non-viral, progressive liver diseases, today announced the results of two new analyses of the POISE trial, the Phase 3 trial of Ocaliva (obeticholic acid) for the treatment of primary biliary cirrhosis, recently renamed primary biliary cholangitis (PBC). The analyses, presented at the International Liver Congress 2016, the 51st Annual Meeting of the European Association for the Study of the Liver (EASL), examined a risk model to predict estimated liver transplant-free survival of patients in the POISE trial and assessed a titration strategy for managing treatment-related pruritus. Ocaliva is an investigational product and has not been granted marketing authorization or approval from any regulatory authority.

The effects of Ocaliva on patient outcomes in PBC have not been directly evaluated, but in the first analysis, researchers from Erasmus University Medical Center used a risk model developed by the Global PBC Study Group to predict liver transplant-free survival in patients treated with Ocaliva or placebo. Of 216 randomized patients in the POISE trial, 93% continued receiving ursodeoxycholic acid (UDCA), the current standard of care and only approved medication for PBC, upon initiating Ocaliva or placebo. The trial's primary endpoint was defined as a reduction in serum alkaline phosphatase (ALP) to below a threshold of 1.67 times upper limit normal, with a minimum of 15% reduction in ALP level from baseline, and a normal bilirubin level after 12 months of therapy. The Global PBC Study Group used data collected from more than 4,000 patients to construct and validate its risk model, with age at the beginning of UDCA therapy, total bilirubin, ALP, platelet count, and albumin following 12 months of treatment with UDCA identified as independent predictors of liver transplant-free survival. After one year, the model suggests patients treated with Ocaliva ±UDCA had significantly improved estimated liver transplant-free survival compared to the group treated with placebo ±UDCA (p<0.0001).

The second analysis utilizing the POISE study data examined the titration strategy used in the trial to address treatment-related pruritus. Pruritus is a common symptom of PBC and mild to moderate pruritus was the most common adverse event observed in POISE. The titration strategy — initiating Ocaliva at 5 mg and titrating up to 10 mg based on clinical response at six months — helped mitigate both the incidence and severity of pruritus, resulting in a single patient discontinuing Ocaliva in the titration group over 12 months of treatment. Despite an early increase at two weeks, patient-reported pruritus severity improved over the course of the study and by month six the Ocaliva 10 mg group and placebo ±UDCA group were similar. Additionally, titration appeared to delay time to onset in the subset of patients who experienced pruritus, with a median of 24 days in the titration group vs. nine days in the group initiating Ocaliva treatment at 10 mg. The authors noted that the AASLD and EASL Clinical Practice Guidelines for the treatment of cholestatic pruritus may also be used for management of Ocaliva-induced pruritus.

"The POISE trial has given us a number of important insights about Ocaliva's potential role as a new therapeutic option for patients with PBC," said Marlyn Mayo, M.D., Associate Professor, Internal Medicine, University of Texas Southwestern Medical Center, and lead author of the titration analysis. "Ocaliva treatment reduced ALP, a biochemical marker we use to track disease progression and a component of risk models used to predict long-term outcomes in patients with PBC. Additionally, our analysis suggests that the titration approach used in POISE may provide physicians and patients with a strategy to help reduce drug-induced pruritus."

Ocaliva is not approved for use by FDA, EMA or any other regulatory body. No conclusions can be drawn concerning the safety or efficacy of Ocaliva at this time.
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Source: press release, 4/14/16. http://ir.interceptpharma.com/releasedetail.cfm?ReleaseID=96501

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Intercept Presents New PBC Data at AASLD 2015

Research Demonstrates Scope of Unmet Need in PBC

New Analysis of Phase 3 POISE Study Uses Risk Algorithm to Examine Potential of OCA to Lower Patients' Long-Term Risk of Liver Transplant and Liver-Related Death

NEW YORK, Nov. 14, 2015 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc. (Nasdaq:ICPT), a clinical stage biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat chronic underserved liver diseases, today announced results from three studies in primary biliary cirrhosis, recently renamed primary biliary cholangitis (PBC), that will be presented at the American Academy for the Study of Liver Diseases (AASLD) Annual Meeting (The Liver Meeting®) in San Francisco, CA from November 14-16. The studies evaluate investigational use of obeticholic acid (OCA), Intercept's lead farnesoid X receptor (FXR) agonist, for the treatment of PBC, the epidemiology of PBC, and both patient and physician perceptions of PBC care. Taken together, the following oral and poster presentations provide more information about the unmet need and treatment goals for PBC.

Clinical Epidemiology of Primary Biliary Cirrhosis based on a Large U.S. Laboratory Database: Incidence and Trends in Serum Alkaline Phosphatase

In an oral presentation, researchers will share results from an analysis of a clinical database of more than 575,000 patients who received an anti-mitochondrial antibody (AMA) test, the principal autoimmune marker used to diagnose PBC in patients with elevated alkaline phosphatase (ALP) levels. Of those patients, 6,107 were classified as having probable PBC based on a positive AMA test and ALP greater than the upper limit of normal at any time prior to AMA testing or up to one month following AMA testing. The study found that the majority (69%) of these likely PBC patients continued to have elevated ALP two years after the first positive AMA test.

"Large-scale epidemiological data on PBC are scarce, so this analysis provides a unique window into ALP trends in this population," said W. Ray Kim, M.D., Stanford University Medical Center, Stanford, CA. "Because PBC patients with elevated ALP levels are at risk of negative outcomes, including potential liver transplant or death, these results suggest a larger unmet need than previously thought for better management of PBC."

A Trial-Based Model of Liver Transplant and Liver-Related Death in Patients with Primary Biliary Cirrhosis

In this oral presentation, researchers will discuss an analysis of data from the Phase 3 POISE trial of OCA in PBC using the UK-PBC predictive model of transplant-free survival based on ALP, bilirubin, alanine transaminase (ALT), albumin and platelet count. Risk was assessed at 5, 10 and 15 years based on a 12-month change from baseline in patients treated with OCA ± ursodiol or placebo ± ursodiol at the end of the POISE study. In the analysis, the UK-PBC risk algorithm showed a significantly lower risk of liver transplant or liver-related death in OCA-treated patients compared to placebo ± ursodiol.

"This analysis is the first to evaluate the potential of OCA to lower patients' long-term risk of liver transplant and liver-related death using the risk algorithm of the UK-PBC research group," said Marco Carbone, M.D., Academic Department of Medical Genetics, University of Cambridge, Cambridge, U.K. "There is an urgent need for new therapy options in PBC that can help patients who have been unable to achieve treatment goals with the current standard of care."

Physician versus Patient Perceptions of Medical Care Quality in Primary Biliary Cirrhosis

This poster will highlight results from a survey examining perceptions of PBC among gastroenterologists (262), hepatologists (60) and patients (214). Patient and physician responses to questions about PBC-related information, PBC diagnosis and treatment, and patient quality of life were broadly similar. However, only approximately one in three PBC patients surveyed knew their most recent ALP score, despite 64% of physicians stating they rely on ALP to monitor the disease. Additionally, although most physicians reported discussing the relationship between PBC symptoms and disease progression with their patients, just one in three patients surveyed understood that worsening PBC symptoms are not an indication of worsening disease. The researchers concluded that improving communication between physicians and patients could enhance patient care.

"These survey results underscore an important opportunity to improve the dialogue about PBC treatment goals between physicians and patients," said David Shapiro, M.D., Intercept's Chief Medical Officer & Executive Vice President, Development. "A large and growing body of research shows that lowering ALP can help reduce the risk of liver transplant and death in PBC, and we are committed to helping patients access both the treatment and educational support needed to improve care."
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Source: press release, 11/14/15. http://ir.interceptpharma.com/releasedetail.cfm?ReleaseID=942755

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Apr 12, 2014

Intercept Reports Additional Positive Data From POISE Trial at EASL Late-Breaker Session

-Notable Improvements on Key Endpoints as Early as Two Weeks After OCA Treatment Initiation

-Titration Regimen Well Tolerated With Pruritus Incidence and Severity Diminishing Over Course of Treatment

NEW YORK, April 12, 2014 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc. (Nasdaq:ICPT) (Intercept) today announced efficacy and safety results from the Phase 3 POISE trial of obeticholic acid (OCA) for the treatment of primary biliary cirrhosis (PBC) to be presented in a late-breaker session at the International Liver Congress of the European Association for the Study of the Liver (EASL). OCA, Intercept's lead product candidate, is a bile acid analog and first-in-class agonist of the farnesoid X receptor (FXR) in development for PBC, nonalcoholic steatohepatitis (NASH) and other liver and intestinal diseases.

As previously reported, the POISE trial met its primary endpoint with high statistical significance (p < 0.0001), demonstrating OCA's efficacy on a composite liver biochemical endpoint which has been shown to strongly correlate with improved clinical outcomes. The proportion of patients meeting the POISE primary endpoint was: 10% in the placebo group, 47% in the 10 mg OCA group and 46% in the 5-10 mg OCA group (both dose groups p < 0.0001 vs placebo). New data in today's presentation show that OCA treated patients achieved a highly statistically significant reduction in alkaline phosphatase (ALP) as early as two weeks, with a peak effect achieved by six months.

Pruritus, generally mild to moderate, was the most frequently reported adverse event in the POISE trial. However, only one (1%) of the patients in the OCA 5-10 mg titration group discontinued therapy due to pruritus after moving up to the 10 mg dose, as compared to seven (10%) of the patients in the 10 mg OCA group. Additional data presented today show that the incidence and severity of OCA related pruritus diminishes with time on therapy. Specifically, pruritus scores were no different from placebo in both OCA treatment groups during the second half of the trial.

"After many years without any new developments in the treatment of PBC, we have finally reached a turning point," said Frederik Nevens, M.D., Ph.D., Chairman of the Department of Hepatology at the University of Leuven, Belgium and the POISE trial's lead investigator. "These data clearly demonstrate that OCA is effective in reducing ALP and other liver enzymes in patients who failed to respond adequately to standard therapy for many years. In addition and importantly, we were able to find a dosing approach that markedly increased tolerability for patients. Patients starting with a 5 mg dose and the option to titrate up to 10 mg experienced less pruritus, but achieved similar rates of ALP and other liver enzyme reduction compared to patients who were treated with a 10 mg dose."

Collette Thain, M.B.E., founder of The United Kingdom PBC Foundation and a PBC patient, said, "At the time of my diagnosis, little was known about this rare autoimmune disease, and diagnosis was a long and stressful process. Since then, awareness has increased significantly, but there remains only one approved treatment for PBC: ursodiol (UDCA), to which not all patients have an adequate response. The Foundation and I are delighted to see research being conducted to provide the medical community with new options for treating patients with PBC."

Separately, in a poster presentation at the International Liver Congress, researchers presented a retrospective analysis of two Phase 2 trials of OCA for the treatment of PBC in a total of 224 patients. Pooled results from these trials were evaluated using the Phase 3 POISE trial endpoint. This analysis showed that overall 43% of patients receiving 10 mg, 25 mg or 50 mg of OCA met the POISE primary endpoint, compared with 8% who received placebo (p < 0.0001), corroborating the Phase 3 results. Moreover, a strong OCA treatment effect was observed regardless of whether OCA was administered as monotherapy or as an add-on to existing ursodiol. OCA treatment was generally well-tolerated, with pruritus, primarily mild or moderate, being the most common adverse event.

"We believe OCA can fill a major gap in the treatment of PBC by providing an effective second-line therapy for the up to 50% of patients who do not achieve an adequate response with ursodiol, the current standard of care," said Mark Pruzanski, M.D., chief executive officer of Intercept. "The POISE trial represents the culmination of more than a decade of work and this important milestone would not be possible without the dedication of researchers, clinicians and patients around the globe."

Intercept plans to submit data from the Phase 3 POISE trial and the two Phase 2 trials of OCA for the treatment of PBC as part of a New Drug Application to the U.S. Food and Drug Administration and a Marketing Authorization Application to the European Medicines Agency. These regulatory filings are currently anticipated at the end of 2014.

POISE Clinical Results

As previously reported, OCA, at both a 10 mg dose and a 5 mg dose titrated to 10 mg, met the trial's primary endpoint of achieving a reduction in ALP to < 1.67x ULN with a ≥ 15% reduction from baseline and a normal bilirubin level after 12 months of therapy. The placebo group experienced a mean decrease in ALP from baseline of 5%, compared to a significant mean decrease of 39% in the 10 mg OCA dose group and 33% in the 5-10 mg OCA titration group (both OCA dose groups p < 0.0001 vs placebo).

In addition to a reduction in ALP levels, treatment with OCA met pre-specified secondary endpoints. Intercept's presentation today provides additional details on reductions in gamma-glutamyl transferase (GGT) of 64% and 50%, alanine transaminase (ALT) of 42% and 36%, aspartate transaminase (AST) of 24% and 22%, in each case for the 10 mg and 5-10 mg OCA dose groups, respectively (both OCA dose groups p < 0.0005 vs placebo). The company's presentation today also provides additional details on lipid observations in the POISE trial, including modest but significant decreases in triglycerides, VLDL cholesterol and HDL cholesterol in both OCA dose groups. No change in LDL cholesterol was observed.

As previously reported, the incidence of adverse events was generally similar across both OCA and placebo groups (placebo: 90%, OCA 10 mg: 86%, OCA 5-10 mg titration: 89%). Pruritus, generally mild to moderate, was the most frequently reported adverse event associated with OCA treatment (placebo: 38%, OCA 10 mg: 68%, OCA 5-10 mg titration: 56%). Eight patients discontinued due to pruritus: none in the placebo group, seven (10%) of the patients in the 10 mg OCA group, and only one (1%) of the patients in the OCA 5-10 mg titration group. Overall, serious adverse events (SAEs) occurred in 22 (10%) of the patients and, although there were more SAEs in the OCA treatment groups, none were considered drug-related and there were no apparent patterns in the SAEs.
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Source: press release, 4/12/14. http://ir.interceptpharma.com/releasedetail.cfm?ReleaseID=839857

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Mar 16, 2014

Intercept Announces Positive Pivotal Phase 3 POISE Trial Results

-OCA Meets Primary Endpoint With High Statistical Significance of p < 0.0001

-Company to Conduct Conference Call and Webcast March 17, 2014 at 8:30 a.m. ET

NEW YORK, March 16, 2014 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc. (Nasdaq:ICPT) (Intercept) today announced that its international Phase 3 POISE trial of obeticholic acid (OCA) for the treatment of primary biliary cirrhosis (PBC) demonstrated that OCA, at both a 10 mg dose and a 5 mg dose titrated to 10 mg, met the trial's primary endpoint of achieving a reduction in serum alkaline phosphatase (ALP) to < 1.67x ULN with a ≥ 15% reduction from baseline and a normal bilirubin level after 12 months of therapy. The proportion of patients meeting the POISE primary endpoint was: 10% in the placebo group, 47% in the 10 mg OCA group and 46% in the 5-10 mg OCA group (both dose groups p < 0.0001 vs placebo) in an intention to treat analysis. The placebo group experienced a mean decrease in ALP from baseline of 5%, compared to a significant mean decrease of 39% in the 10 mg OCA dose group and 33% in the 5-10 mg OCA titration group (both dose groups p < 0.0001 vs placebo). In addition, both OCA dose groups met pre-specified secondary endpoints of improvements in other liver function parameters, including GGT, ALT, AST and total bilirubin (both dose groups p < 0.0005 vs placebo).

OCA, Intercept's lead product candidate, is a bile acid analog and first-in-class agonist of the farnesoid X receptor (FXR) in development for PBC, nonalcoholic steatohepatitis (NASH) and other liver and intestinal diseases.

"These POISE trial results indicate that OCA clearly produced clinically meaningful improvements, not only in the primary endpoint but also across a broad range of biochemical liver function parameters," said Professor Frederik Nevens, M.D. Ph.D., Chairman of the Department of Hepatology at the University of Leuven, Belgium and the lead investigator in POISE. "While ursodiol has been the mainstay of PBC therapy for the past 20 years, a significant proportion of patients fail to get an adequate response with this drug and we need new therapies to prevent their disease progressing to cirrhosis and liver failure. I believe that the POISE data indicate OCA will provide a meaningful clinical improvement in these patients."

"POISE is Intercept's third successful international, placebo controlled trial of OCA in PBC patients conducted over the past seven years, setting the stage for our anticipated filing for approval of OCA in the U.S., Europe and other countries," said David Shapiro, M.D., Chief Medical Officer of Intercept. "With the results of POISE and our ongoing long-term study of PBC patients on therapy for more than four years, we have shown that OCA produces a significant durable response and believe this will result in better clinical outcomes for many patients. We would like to thank the many investigators and patients who participated in POISE and our other PBC trials."

Primary Endpoint & Clinical Outcomes

In order to evaluate the clinical relevance of the POISE primary endpoint, Intercept sponsored an independent study conducted by the Global PBC Study Group (the 'PBC Supergroup'), consisting of 15 leading PBC centers in eight countries that contributed to a clinical outcomes database of more than 6,000 PBC patients. In this study, patients who did not achieve the POISE endpoint after one year were shown to have a greatly increased risk of liver transplant or death compared to those who achieved the endpoint (Hazard Ratio 2.83, p=1x10-34). The PBC Supergroup has also previously confirmed that higher ALP levels in patients correlate with increased risk of liver transplant and death.

Safety and Tolerability

Pruritus, generally mild to moderate, was the most frequently reported adverse event associated with OCA treatment (placebo: 38%, OCA 10 mg: 68%, OCA 5-10 mg titration: 56%). Eight patients discontinued due to pruritus: none in the placebo group, seven (10%) of the patients in the 10 mg OCA group, and only one (1%) of the patients in the OCA 5-10 mg titration group. Apart from pruritus, the incidence of adverse events was generally similar across both OCA and placebo groups (placebo: 90%, OCA 10 mg: 86%, OCA 5-10 mg: 89%). Overall, serious adverse events (SAEs) occurred in 22 (10%) of the patients and, although there were more SAEs in the OCA treatment groups, none were considered drug-related and there were no apparent patterns in the SAEs. PBC patients typically have significantly elevated HDL cholesterol levels and modest decreases in HDL were observed in both OCA dose groups, similar to those seen in the prior PBC clinical trials. In addition, slight decreases in triglycerides but no change in LDL cholesterol were observed in the OCA dose groups.

The POISE trial results will be presented in greater detail at the upcoming International Liver Congress of the European Association for the Study of the Liver (EASL) in April 2014.

Conference Call and Webcast at 8:30 a.m. ET

Intercept will discuss the results of the POISE trial during the previously announced conference call and audio webcast scheduled to take place on Monday, March 17, 2014 at 8:30 a.m. ET. The live event will be available on the investor page of our website at http://ir.interceptpharma.com or by calling (855) 232-3919 (toll-free domestic) or (315) 625-6894 (international) five minutes prior to the start time. A replay of the call will be available on the Intercept website approximately two hours after the completion of the call and will be archived for two weeks.
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Source: press release, 3/16/14. http://ir.interceptpharma.com/releasedetail.cfm?ReleaseID=833072

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