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Lead Product(s): Deuterium-stabilized R-pioglitazone
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: PXL065
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 November 16, 2020
Details:
Analysis of results from the Phase 1b study of PXL065 (deuterium-stabilized R-pioglitazone) predicts efficacy at 15 mg once-daily is equivalent to 45 mg Actos®*, with little to no PPARg-related side effects, such as weight gain.
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Lead Product(s): Lanifibranor
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: IVA 337
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 November 10, 2020
Details:
FDA confirms that a single Phase III clinical trial may be adequate for submitting U.S. marketing authorization application for lanifibranor.
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Lead Product(s): Pioglitazone
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: PXL065
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 November 09, 2020
Details:
Results from its Phase 1b study of PXL065 and results from three preclinical studies for PXL770 will be presented as e-posters at The Liver Meeting® 2020 hosted by the American Association for the Study of Liver Diseases (AASLD).
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Lead Product(s): Lanifibranor
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: IVA 337
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 November 02, 2020
Details:
Two late-breaking abstracts covering new data from Inventiva’s NATIVE Phase IIb clinical trial evaluating lanifibranor for the treatment of NASH have been selected for poster presentations during the congress.
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Lead Product(s): Lanifibranor
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: IVA 337
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 October 12, 2020
Details:
Designation based on positive topline results from NATIVE Phase IIb clinical trial evaluating lanifibranor in non-alcoholic steatohepatitis (NASH).
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Lead Product(s): Lanifibranor
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: IVA 337
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 October 05, 2020
Details:
Lanifibranor met primary endpoint with significant reduction of the Steatosis Activity Fibrosis score, which combines assessments of hepatocellular inflammation and ballooning, with no worsening of fibrosis in the Intention To Treat and Per Protocol populations.
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Lead Product(s): PXL770
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: PXL770
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 October 01, 2020
Details:
The Phase 2a trial for the treatment of NASH met its primary efficacy endpoint; PXL770-treated patients achieved statistically significant improvement in the relative decrease in liver fat mass MRI-PDFF at 12-weeks with a greater response in patients with type 2 diabetes.
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Lead Product(s): Pioglitazone
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: PXL065
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 September 02, 2020
Details:
Phase 2 trial will include approximately 120 noncirrhotic biopsy-proven NASH patients and is designed to identify optimal dose or doses for Phase 3 registration trial.
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Lead Product(s): Setanaxib
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: GKT831
Highest Development Status: Phase II Product Type: Small molecule
Partner/Sponsor/Collaborator: Genkyotex
Deal Size: $37.7 million Upfront Cash: Undisclosed
Deal Type: Acquisition August 13, 2020
Details:
Transaction adds orphan pipeline asset and platform in inflammation and fibrosis. Genkyotex’s lead clinical candidate, setanaxib, is in development for Primary Biliary Cholangitis.
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Lead Product(s): Lanifibranor
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: IVA 337
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 06, 2020
Details:
Following higher than expected effects on steatosis reduction during the Phase IIb NATIVE trial in NASH, the number of patients to be recruited in the trial evaluating lanifibranor in patients with T2DM and NAFLD has been reduced to 34 (vs. 64 initially).
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