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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): Tvb-2640

            Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: ASC40

            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 October 06, 2020

            Details:

            In this randomized, placebo-controlled trial, a novel, first-in-class, FASN inhibitor, TVB-2640 significantly decreased liver fat and serum biomarkers of liver injury, fibrosis and inflammation with an excellent safety profile and tolerability.

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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 October 02, 2020

            Details:

            Efruxifermin (EFX), a long-acting Fc-FGF21 fusion protein, administered for 16 weeks to patients with NASH substantially reduces liver fat and ALT, and improves liver histology.

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            Lead Product(s): Seladelpar

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

            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 October 01, 2020

            Details:

            Presentation will highlight results from a 52-Week multi-center double-blind randomized Phase 2 Study of Seladelpar, in Patients with Nonalcoholic Steatohepatitis (NASH).

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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 September 30, 2020

            Details:

            The primary objective of the expansion cohort is to assess safety and tolerability of EFX in NASH patients at the greatest risk of progressing to end-stage liver disease, including liver failure and liver cancer.

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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 September 24, 2020

            Details:

            Under the planned adaptive trial design, Akero will evaluate two Efruxifermin doses in a 24-week Phase 2b portion of the trial to inform selection of a single dose for evaluation in the Phase 3 portion of the study.

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            Lead Product(s): Terlipressin

            Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: BIV201

            Highest Development Status: Phase II Product Type: Large molecule

            Partner/Sponsor/Collaborator: ThinkEquity

            Deal Size: $18.0 million Upfront Cash: Undisclosed

            Deal Type: Public Offering September 23, 2020

            Details:

            The Company intends to use the net proceeds from the offering primarily to fund clinical trials of its lead product candidate BIV201 and for working capital and other general corporate purposes.

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            Lead Product(s): DUR-928

            Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: DUR-928

            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 September 22, 2020

            Details:

            AHFIRM is a randomized, double-blind, placebo-controlled, international, multi-center Phase 2b study to evaluate the safety and efficacy of DUR-928 in approximately 300 patients with severe AH.

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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 September 21, 2020

            Details:

            The LiFT Phase 2 clinical study is a 38-week, prospective, multi-center, randomized, double-blind, placebo-controlled, three-arm study of LPCN 1144 in biopsy-confirmed male NASH subjects (based on NAFLD activity score) with grade F1-F3 fibrosis.

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            Lead Product(s): VK2809

            Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: VK2809

            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 August 28, 2020

            Details:

            Highlights from the oral presentation include newly reported data demonstrating that patients treated with VK2809 experienced durable, statistically significant reductions in liver fat content that were maintained at Week 16.

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            Lead Product(s): DUR-928

            Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: DUR-928

            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 August 27, 2020

            Details:

            Data from a Phase 2a study of DUR-928 in alcoholic hepatitis (AH) at the Digital International Liver Congress™ 2020 (EASL)DUR-928 was well tolerated at all doses tested in 19 AH patients, including 12 severe AH patients.

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