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Ascletis Pharma

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Gannex Announces Clinical Trial Application of ASC42, an FXR Agonist, for Treatment of Primary Biliary Cholangitis Accepted by China NMPA

Details:

ASC42 is a novel non-steroidal, selective, potent FXR agonist with best-in-class potential. Gannex announced positive topline results of safety and pharmacodynamic biomarkers from the U.S. Phase I trial of ASC42 where there was no pruritus observed during 14-day treatment.

Lead Product(s): ASC42

Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: ASC42

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 September 05, 2021

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Eccogene

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Eccogene Announces Completed First-in-human of ECC0509 in Phase 1a Clinical Trial in Australia

Details:

The trial is a Phase 1, randomized, double-blind, placebo-controlled, sequential single- and multiple ascending dose clinical trial to evaluate the safety, pharmacokinetics, pharmacodynamics of ECC0509 in healthy volunteers.

Lead Product(s): ECC0509

Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: ECC0509

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 July 28, 2021

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Ascletis Pharma

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Gannex Received China IND Approval of Its FXR Agonist ASC42 for NASH Indication

Details:

ASC42 is an in-house developed, novel non-steroidal, selective, potent Farnesoid X Receptor (FXR) agonist with best-in-class potential. ASC42 is an oral tablet formulation developed with in-house proprietary technology and is stable at room temperature for NASH indication.

Lead Product(s): ASC42

Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: ASC42

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 26, 2021

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Sciwind

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Sciwind's Investigational New Drug Approved for NASH Trial

Details:

XW003, a potential candidate for the treatment of non-alcoholic steatohepatitis (NASH), has been approved by China NMPA for clinical trial.

Lead Product(s): XW003

Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: XW003

Highest Development Status: Phase I Product Type: Peptide

Partner/Sponsor/Collaborator: Novotech

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable February 28, 2021

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Ascletis Pharma

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First Subject Dosed with Gannex's FXR Agonist ASC42 in a U.S. Phase I Trial

Details:

This U.S. phase I trial will evaluate safety, tolerability, pharmacokinetics and pharmacodynamics (biomarkers - FGF19 and C4) of ASC42 in healthy subjects. This trial also investigates the food effect on ASC42 exposure.

Lead Product(s): ASC42

Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: ASC42

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 December 28, 2020

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