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

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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): Elafibranor

            Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: GFT505

            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 24, 2020

            Details:

            ELATIVE™ is a randomized, double blind, placebo-controlled, global multicenter Phase 3 study evaluating the efficacy and safety of elafibranor, a dual PPAR alpha and delta agonist, in PBC.

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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.

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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 August 27, 2020

            Details:

            This electronic presentation highlights the efficacy, safety, and tolerability of seladelpar over 1 year of open-label treatment.

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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 August 27, 2020

            Details:

            Additional data indicate that obeticholic acid (OCA) helped patients with nonalcoholic steatohepatitis (NASH) achieve sustained improvements in liver biochemistry and noninvasive markers of liver fibrosis over two years of treatment.

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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 August 26, 2020

            Details:

            MRI-PDFF reduction has been shown to be associated with improvement in NASH components as assessed on liver biopsy. These secondary analyses of Madrigal’s Phase 2 NASH clinical trial add significant additional insight into the potential of PDFF to predict NASH response.

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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 August 03, 2020

            Details:

            The study demonstrated seladelpar to be efficacious, safe and well-tolerated . 78.2% of patients on seladelpar 10 mg versus 12.5% on placebo achieved the primary composite outcome after only 3 months.

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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 July 23, 2020

            Details:

            CymaBay had halted all studies of seladelpar after liver biopsies showed some patients in a phase 2b NASH trial had inflamed and destroyed liver cells, a condition known as interface hepatitis.

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            Lead Product(s): Obeticholic Acid

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

            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 July 21, 2020

            Details:

            Viewing the evidence from the study as a whole, ICMR feels that the long-term net effects of OCA on quality of life and health of patients with NASH and F2/F3 fibrosis are uncertain.

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