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Find Drugs for Hepatology (Liver, Pancreatic, Gall Bladder) in Phase III Clinical Development in UNITED STATES

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            Lead Product(s): Odevixibat

            Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: A4250

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable December 08, 2020

            Details:

            Odevixibat is a potent, once-daily, non-systemic ileal bile acid transport inhibitor (IBATi) being developed to treat rare pediatric cholestatic liver diseases, including PFIC, biliary atresia and Alagille syndrome.

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            Lead Product(s): Seladelpar

            Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: MBX-8025

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable November 16, 2020

            Details:

            Results highlight the potential for seladelpar to offer patients an efficacious and safe second line treatment option. Seladelpar demonstrated anti-cholestatic, anti-inflammatory, and anti-pruritic activity through 3 and 6 months.

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            Lead Product(s): Obeticholic Acid

            Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: Undisclosed

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable November 16, 2020

            Details:

            REGENERATE is a Phase 3, randomized, double-blind, placebo-controlled, multicenter study assessing the safety and efficacy of obeticholic acid (OCA) on clinical outcomes in patients with liver fibrosis due to NASH, an investigational use.

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            Lead Product(s): Resmetirom

            Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: MGL-3196

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable November 13, 2020

            Details:

            Resmetirom is the first orally administered, small-molecule, liver-directed, truly β-selective thyroid hormone receptor (THR) agonist and is currently in Phase 3 development for the treatment of NASH patients both with biopsy-confirmed fibrosis stage 2-3.

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            Lead Product(s): Resmetirom

            Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: MGL-3196

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable November 05, 2020

            Details:

            Resmetirom is a liver-directed, small-molecule and a truly β-selective thyroid hormone receptor agonist. Madrigal has completed enrollment in its MAESTRO NAFLD-1 trial of resmetirom in patients with presumed NASH who are diagnosed using non-invasive assessments.

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            Lead Product(s): Seladelpar

            Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: MBX-8025

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable November 02, 2020

            Details:

            The oral presentation titled “ENHANCE: Safety and Efficacy of Seladelpar in Patients with Primary Biliary Cholangitis (PBC) – A Phase 3 International, Randomized, Placebo-Controlled Study,” 1 will be delivered by Professor Gideon Hirschfield, MD, University of Toronto.

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            Lead Product(s): Obeticholic Acid

            Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: Undisclosed

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable October 29, 2020

            Details:

            Presentations include Ocaliva efficacy and safety data in patients with PBC treated for up to six years, new data from the interim analysis of the Phase 3 REGENERATE study.

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            Lead Product(s): Resmetirom

            Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: MGL-3196

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable October 01, 2020

            Details:

            The data from the ongoing open label arm of MAESTRO-NAFLD-1 confirm the robust effects of a 100 mg dose of resmetirom with direct actions in the liver at 16 weeks to significantly reduce both hepatic fat on serial MRI-PDFF as well as meaningfully reduce liver fibrosis.

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            Lead Product(s): Resmetirom

            Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: MGL-3196

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 03, 2020

            Details:

            Recent presentations at EASL Digital ILC of secondary analysis of Ph2 data demonstrated that reduction in MRI-PDFF can predict improvement in all components of histologic response in NASH, including steatosis, ballooning, inflammation and fibrosis.