Hepatology (Liver, Pancreatic, Gall Bladder) | Phase I Developments | UNITED STATES

CohBar

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CohBar Resumes CB4211 Phase 1b Clinical Trial

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.

Hepion Pharmaceuticals

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Hepion Pharmaceuticals' CRV431 Demonstrates Efficacy in Kidney Fibrosis

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).

Hepion Pharmaceuticals

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Hepion Pharmaceuticals' CRV431 the First Cyclophilin Inhibitor to Advance to Phase 2 Trial for NASH Fibrosis

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.

CohBar

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CohBar delays CB4211 Phase 1b Study for NASH and Obesity

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.

Pliant Therapeutics

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Pliant Therapeutics Initiates First-in-Human Clinical Trial of PLN-1474 for the Potential Treatment of Liver Fibrosis

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.

Terns Pharmaceuticals

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Terns Pharmaceuticals to Present Data from an Ongoing Phase 1 Clinical Trial of TERN-201, a SSAO Inhibitor in Development for NASH

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.

Arrowhead Pharmaceuticals

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Arrowhead Pharmaceuticals Initiates Phase 1/2 Study of ARO-HSD

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.

Terns Pharmaceuticals

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Terns Pharmaceuticals Announces Safety and Pharmacodynamic Results of a Phase 1 Clinical Trial of TERN-101

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.

Hepion Pharmaceuticals

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Hepion Pharmaceuticals Announces Advancement to Third Dose Level in Ongoing Multiple Ascending Dose Clinical Study of CRV431

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.

Metacrine

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Metacrine Demonstrates Best-in-Class FXR Drug Program with Positive Clinical Results in NASH Patients

Lead Product(s): MET409

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 January 22, 2020

Details:

Randomized, placebo-controlled 12-week study showed mean liver fat reduction of up to 55% with MET409

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

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CohBar

CohBar Resumes CB4211 Phase 1b Clinical Trial

Hepion Pharmaceuticals

Hepion Pharmaceuticals' CRV431 Demonstrates Efficacy in Kidney Fibrosis

Hepion Pharmaceuticals

Hepion Pharmaceuticals' CRV431 the First Cyclophilin Inhibitor to Advance to Phase 2 Trial for NASH Fibrosis

CohBar

CohBar delays CB4211 Phase 1b Study for NASH and Obesity

Pliant Therapeutics

Pliant Therapeutics Initiates First-in-Human Clinical Trial of PLN-1474 for the Potential Treatment of Liver Fibrosis

Terns Pharmaceuticals

Terns Pharmaceuticals to Present Data from an Ongoing Phase 1 Clinical Trial of TERN-201, a SSAO Inhibitor in Development for NASH

Arrowhead Pharmaceuticals

Arrowhead Pharmaceuticals Initiates Phase 1/2 Study of ARO-HSD

Terns Pharmaceuticals

Terns Pharmaceuticals Announces Safety and Pharmacodynamic Results of a Phase 1 Clinical Trial of TERN-101

Hepion Pharmaceuticals

Hepion Pharmaceuticals Announces Advancement to Third Dose Level in Ongoing Multiple Ascending Dose Clinical Study of CRV431

Metacrine

Metacrine Demonstrates Best-in-Class FXR Drug Program with Positive Clinical Results in NASH Patients