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

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            Lead Product(s): Insulin

            Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: ORMD-0801

            Highest Development Status: Phase II Product Type: Peptide

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable December 02, 2020

            Details:

            Oramed has screened the first patients in a global trial of its oral insulin capsule ORMD-0801 for the treatment of Nonalcoholic steatohepatitis (NASH). The trial will measure efficacy endpoints via MRI-PDFF for 12-weeks dosing.

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            Lead Product(s): Yeast recombinant lipase

            Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: MS1819

            Highest Development Status: Phase II Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable November 17, 2020

            Details:

            The proposed amendment will add a study arm that uses an immediate release MS1819 capsule, allowing the Company to compare data from the existing arm that uses enteric (delayed release) capsules with data from the new arm, and ultimately select the optimal delivery method.

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            Lead Product(s): Semaglutide,Cilofexor,Firsocostat

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

            Highest Development Status: Phase II Product Type: Peptide

            Partner/Sponsor/Collaborator: Novo Nordisk

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable November 15, 2020

            Details:

            The five-arm trial evaluated combinations of Novo Nordisk’s semaglutide, a GLP-1 receptor agonist, with Gilead’s investigational FXR agonist cilofexor and/or Gilead’s investigational ACC inhibitor firsocostat over 24 weeks in 108 people with non-alcoholic steatohepatitis.

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            Lead Product(s): Efruxifermin

            Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: AKR-001

            Highest Development Status: Phase II Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable November 13, 2020

            Details:

            Data show large magnitudes of reduction in liver fat across all Efruxifermin (EFX) dose groups with 100% of participants in the 50mg EFX dose group achieving >50% relative liver fat reduction and 53% in the same dose group achieving >70% relative liver fat reduction.

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            Lead Product(s): CRV431

            Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: CRV431

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable November 12, 2020

            Details:

            The poster presentation will review positive findings from an expanded study where CRV431, prevented experimentally induced liver fibrosis to a greater extent than four other leading NASH drug candidates in a human precision cut liver slices experimental model.

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            Lead Product(s): Rifaximin

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

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Bausch Health

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable November 11, 2020

            Details:

            Salix going present two scientific posters featuring rifaximin data at the American Association for the Study of Liver Diseases (AASLD) annual meeting, The Liver Meeting Digital Experience, which will take place.

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            Lead Product(s): Testosterone Undecanoate

            Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: LPCN 1144

            Highest Development Status: Phase II 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:

            Company will present a poster with results from a preclinical study investigating LPCN 1144 treatment on hepatic fibrosis and non-alcoholic steatohepatitis features at The Liver Meeting Digital Experience™, hosted by the American Association for the Study of Liver Diseases.

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            Lead Product(s): Aldafermin

            Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: NGM282

            Highest Development Status: Phase II Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable November 04, 2020

            Details:

            Multiple aldafermin presentations, including a late-breaking oral presentation and comprehensive data from its 24-week Phase 2 study (Cohort 4) of aldafermin in patients with non-alcoholic steatohepatitis (NASH), will be featured at AASLD’s The Liver Meeting®.