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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
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.
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Lead Product(s): ASC41
Therapeutic Area: Cardiology/Vascular Diseases Product Name: ASC41
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 22, 2020
Details:
The trial aims to evaluate 1) the impact of ASC41 on markers of cardiac health; 2) the safety and tolerability of ASC41 tablets; 3) the pharmacokinetics of ASC41 tablets and its active moiety, ASC41-A, in overweight and obese subjects.
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Lead Product(s): ASC42
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: ASC42
Highest Development Status: IND Enabling Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 13, 2020
Details:
ASC42 is an in-house developed，novel non-steroidal, selective, potent Farnesoid X Receptor (FXR) agonist with best-in-class potential. In two NASH animal models, ASC42 demonstrated significant improvements in liver steatosis, inflammation and fibrosis.
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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: Sagimet Biosciences
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 19, 2020
Details:
The preliminary data showed that ASC40 (TVB-2640) significantly reduced liver fat, the primary efficacy endpoint of this trial, with a 61% responder rate in the 50 mg group. Participants also showed improvement in markers of liver function and fibrosis.
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Lead Product(s): ASC42
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: ASC42
Highest Development Status: IND Enabling Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 14, 2020
Details:
ASC42 is an in-house developed Farnesoid X Receptor (FXR) agonist. In two NASH animal models, ASC42 demonstrated significant improvements in liver steatosis, inflammation and fibrosis.
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Lead Product(s): ASC42
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: ASC42
Highest Development Status: IND Enabling Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 14, 2020
Details:
ASC42 is an in-house developed Farnesoid X Receptor (FXR) agonist. In two NASH animal models, ASC42 demonstrated significant improvements in liver steatosis, inflammation and fibrosis.
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Lead Product(s): ASC41,Aramchol
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: ASC41
Highest Development Status: Undisclosed Product Type: Small molecule
Partner/Sponsor/Collaborator: Galmed Pharmaceuticals
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration September 10, 2020
Details:
ASC41 is an oral thyroid hormone receptor beta agonist and Aramchol is a novel synthetic small molecule, a conjugate of cholic acid and arachidic acid, linked by a stable amide group. The team will work together combining both the therapies for the treatment of NASH.
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Lead Product(s): Envafolimab
Therapeutic Area: Infections and Infectious Diseases Product Name: ASC22
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 August 17, 2020
Details:
ASC22(Envafolimab) Phase IIa clinical trial is a single dose escalation study with three subcutaneously administered doses (0.3, 1.0 and 2.5 mg/kg) to explore the safety and efficacy of ASC22(Envafolimab) in chronic hepatitis B patients.
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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 July 20, 2020
Details:
This bridging study in China demonstrated linear pharmacokinetic for ASC40 (TVB-2640) from oral, single doses of 25, 50 to 75 mg. ASC40 is safe and well-tolerated in Chinese subjects and majority of adverse events are grade1.
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Lead Product(s): ASC41
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: Undisclosed
Highest Development Status: IND Enabling Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 13, 2020
Details:
Ascletis Pharma received IND approval from China's National Medical Products Administration (NMPA) for its in-house developed Category 1 Drug ASC41 to conduct clinical trials for Non-alcoholic Steatohepatitis (NASH) indication.
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