Intercept Announces Development Program for Next-Generation FXR Agonist INT-787 in Severe Alcohol-Associated Hepatitis
First-in-human data shared at The Liver Meeting® 2022 supported a favorable safety and tolerability profile for INT-787 in healthy adults
Company announces severe alcohol-associated hepatitis (sAH), a disease with no approved therapies, as its lead indication for INT-787
Company initiates Phase 2a FRESH study in patients with sAH
Initial data from Intercept’s ongoing Phase 1 trial of INT-787 in healthy subjects was shared at The Liver Meeting®, the annual meeting of the
“As we begin our Phase 2a trial in patients with sAH, we are encouraged by the efficacy demonstrated in pre-clinical assessments, and the safety and tolerability in our single and multiple-ascending dose, first-in-human studies,” said
In a Phase 1, double-blind, placebo-controlled, single-ascending dose (SAD) and multiple-ascending dose (MAD) study, subjects were randomized to receive INT-787 or placebo (6:2 allocation) in each dose cohort. As of
Results showed INT-787 was generally well tolerated in healthy subjects. No serious adverse events were reported. The majority of treatment-emergent adverse events were mild, and no treatment-limiting adverse events were identified. Mild pruritus was reported in 2 of 122 subjects and was not associated with dose. INT-787 showed rapid absorption with peak plasma concentration at 2 hours post-dose, and exposure increased in a dose-dependent manner. The half-life of total INT-787 ranged from 20 to 43 hours in cohorts with robust exposure. Renal excretion of conjugated INT-787 was observed in urine PK. The apparent steady state for total INT-787 concentration was reached by day 7 in the MAD study.
The Phase 1 study is ongoing and is expected to complete in Q1 2023.
The Phase 2a FRESH study is a randomized, double-blind, dose-escalation study that is expected to enroll approximately 50 patients with sAH across multiple clinical sites in the
About Severe Alcohol-Associated Hepatitis (sAH)
Alcohol-related liver disease (ALD) as a cause of chronic liver disease is on the rise in the
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) and severe alcohol-associated hepatitis (sAH). For more information, please visit www.interceptpharma.com or connect with the Company on Twitter and LinkedIn.
This press release contains forward-looking statements (“FLS”), including regarding our product pipeline, our clinical studies, and our research and development (“R&D”) plans. Important factors could cause actual results to differ materially from the FLS. For example, our clinical studies could be delayed, not reach enrollment targets, have methodological problems, or indicate that a studied drug is not effective, safe, or tolerable. As a result, our pipeline, studies, and R&D initiatives could be unsuccessful.
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Source: Intercept Pharmaceuticals, Inc.