Intercept Pharmaceuticals Hits a Regulatory Hurdle: Late-stage NASH Trial Terminated

AI generated by AppliedXL
October 31, 2023
AI-generated image featuring Therapeutics' logo.
AI-generated image featuring Therapeutics' logo.

Intercept Pharmaceuticals decided to pull the plug on its late-stage trials assessing the impact of the investigational compound Obeticholic Acid Treatment on NASH with fibrosis, following FDA guidance that deemed it unnecessary. This decision was finalized on September 15, 2023, a full two years before the initially set finish line of September 1, 2025. The FDA’s directive stemmed from a Complete Response Letter in relation to the company’s New Drug Application for Obeticholic Acid.

Deep Dive into Obeticholic Acid: Intercept’s Research Overview

  • In its endeavor to put Obeticholic Acid under the lens, Intercept Pharmaceuticals sponsored three clinical trials. This clincial research aimed to evaluate the drug’s effect on conditions ranging from non-cirrhotic nonalcoholic steatohepatitis (NASH) with liver fibrosis to its impact on lipoprotein metabolism in subjects diagnosed with NASH fibrosis stages 1 to 4. 
  • With trials spread across various facilities, the company enrolled a significant 3,483 patients, testing the investigational compound between March 21, 2017, and September 15, 2023.

Other Clinical Studies in Intercept's Pipeline

  • Apart from their focus on Obeticholic Acid, Intercept Pharmaceuticals seeks to assess other investigational compounds. They are currently scrutinizing treatments for Primary Biliary Cholangitis (PBC) in tandem with bezafibrate, aiming for an enrollment conclusion by October 1, 2024. 
  • The company is also eyeing the FXR effect through the FRESH study for severe alcohol-associated hepatitis (sAH), set for completion by December 31, 2023. Both programs currently reside in mid-stage trials examining efficacy and side effects.

The NASH Race: Intercept and Its Competitors

  • Intercept Pharmaceuticals isn’t alone in its quest to tackle NASH and liver fibrosis. The New Jersey based biotech company  faces stiff competition from giants like Novo Nordisk A/S, which is undergoing testing for Semaglutide due by April 07, 2028.
  • Madrigal Pharmaceuticals, Inc. seeks to assess MGL-3196 (Resmetirom) with eyes set on an April 01, 2024, finish. 
  • Inventiva Pharma, on the other hand, is focusing on examining Lanifibranor and its synergy with an SGLT2 inhibitor for patients grappling with NASH and Type 2 Diabetes Mellitus, with research encounters extended timeline set for September 30, 2025.

Sources:, PubMed, Press Releases, and AppliedXL. This report is generated algorithmically and may not cover all ongoing industry-sponsored trials. AppliedXL implements rigorous AI vetting processes but cannot guarantee the completeness of all insights.

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