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

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            Lead Product(s): CB4211

            Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: CB4211

            Highest Development Status: Phase I Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable July 07, 2020

            Details:

            CohBar has resumed the Phase 1b stage of its Phase 1a/1b clinical trial of CB4211, its lead candidate for the treatment of nonalcoholic steatohepatitis (NASH) and obesity.

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            Lead Product(s): CRV431

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

            Highest Development Status: Phase I Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 23, 2020

            Details:

            Mice that underwent left ureter surgical ligation were orally administered either vehicle or CRV431 at a dose of 50 mg/kg/day for two weeks (n=8 mice/group).

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            Lead Product(s): CRV431

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

            Highest Development Status: Phase I Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable May 19, 2020

            Details:

            Hepion Pharmaceuticals has completed the submission of a Phase 1 data memo and the Phase 2a protocol to the FDA, and intends to commence its Phase 2a clinical trial of CRV431 for the treatment of NASH fibrosis in June.

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            Lead Product(s): CB4211

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

            Highest Development Status: Phase I Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable March 30, 2020

            Details:

            This delay is a result of a pause by some of the company’s clinical research organization partners in all of their activities related to the study in response to the COVID-19 pandemic.

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            Lead Product(s): PLN-1474

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

            Highest Development Status: Phase I Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable March 23, 2020

            Details:

            Pliant Therapeutics has dosed the first cohort of healthy participants in a first-in-human Phase 1 clinical trial of PLN-1474 currently being developed for the treatment of NASH with liver fibrosis.

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            Lead Product(s): TERN-201

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

            Highest Development Status: Phase I Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable March 06, 2020

            Details:

            The company will give an oral presentation reviewing Phase 1 data on TERN-201, its semicarbazide-sensitive amine oxidase (SSAO) inhibitor in development for NASH.

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            Lead Product(s): ARO-HSD

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

            Highest Development Status: Phase I Product Type: Undisclosed

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable March 03, 2020

            Details:

            The Phase 1/2 single and multiple dose-escalating study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamic effects of ARO-HSD.

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            Lead Product(s): HM15211

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

            Highest Development Status: Phase I Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable February 28, 2020

            Details:

            Hanmi is planning to begin the global Phase 2 trials of LAPSTriple Agonist in the second quarter this year with biopsy-proven NASH patients.

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            Lead Product(s): TERN-101

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

            Highest Development Status: Phase I Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable February 19, 2020

            Details:

            Phase 1 study demonstrated TERN-101 is safe and exhibits potent target engagement at all dose levels studied.

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            Lead Product(s): CRV431

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

            Highest Development Status: Phase I Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable February 13, 2020

            Details:

            The open-label MAD study is designed to assess safety, tolerability and pharmacokinetics of CRV431, administered orally to healthy volunteers, once daily for 28 days.

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