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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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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 June 24, 2020
Details:
The study met its key objectives; PXL770 was observed to demonstrate a consistent PK profile in the likely-NASH patient population and was observed to be safe and well-tolerated .
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Lead Product(s): Lanifibranor
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: Undisclosed
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 June 15, 2020
Details:
Lanifibranor met the primary endpoint in the ITT population at the dose of 1200mg/day with a statistically significant (p = 0.004) decrease of at least two points in the SAF activity score6, compared to baseline, with no worsening of fibrosis.
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Lead Product(s): PXL770
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: Undisclosed
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 May 25, 2020
Details:
PXL770 treatment was observed to improve cardio-renal disease and adrenoleukodystrophy (ALD) /adrenomyeloneuropathy (AMN) in animal models.
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Lead Product(s): PXL770
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: Undisclosed
Highest Development Status: Phase II Product Type: Small molecule
Partner/Sponsor/Collaborator: JMP Securities LLC
Deal Size: $19.4 million Upfront Cash: Undisclosed
Deal Type: Public Offering May 25, 2020
Details:
The use of proceeds will enable the Company to accelerate the development plans for PXL770 and PXL065 for the treatment of NASH, to pursue development activities in other metabolic diseases and for general corporate purposes.
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Lead Product(s): Lanifibranor
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: Undisclosed
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 March 17, 2020
Details:
Last patient last visit took place in the United States on March 16, 2020. Publication of study head-line results expected for June 2020.
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