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

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)

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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FCE Pharma

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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)

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)

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)

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)

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.

Hanmi Pharm

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FCE Pharma

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Hanmi’s anti-NASH drug candidate set to become ‘game changer’ in global pharmaceutical market

Lead Product(s): HM15211

Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder)

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.

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): LY-2562175

Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder)

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)

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)

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

Hanmi Pharm

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Hanmi Pharma to develop innovative drugs for rare diseases

Lead Product(s): HM15211

Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder)

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 January 16, 2020

Details:

HM12525A is the world's first anti-obesity treatment that works as a once-weekly injection. Its efficacy was proven to be higher than existing daily-injection obesity treatment in Phase 2 trials.

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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

Hanmi Pharm

Hanmi’s anti-NASH drug candidate set to become ‘game changer’ in global pharmaceutical market

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

Hanmi Pharm

Hanmi Pharma to develop innovative drugs for rare diseases