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Lead Product(s): Imeglimin Hydrochloride
Therapeutic Area: Endocrinology Product Name: Undisclosed
Highest Development Status: Phase II Product Type: Small molecule
Partner/Sponsor/Collaborator: Metavant Sciences
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Terminated January 14, 2021
Details:
Metavant will return all rights to Imeglimin to Poxel, as well as all data, materials, and information, including FDA regulatory filings, related to the program. Metavant is not entitled to any payment from Poxel as part of the return of the program.
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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): 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): 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): Imeglimin Hydrochloride
Therapeutic Area: Endocrinology Product Name: Undisclosed
Highest Development Status: Phase III Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 24, 2020
Details:
Phase 3 TIMES 2 and TIMES 3 trial results demonstrate that Imeglimin met its primary endpoints and objectives and was observed to exhibit a favorable safety and tolerability profile.
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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): Imeglimin Hydrochloride
Therapeutic Area: Endocrinology Product Name: Undisclosed
Highest Development Status: Phase III Product Type: Small molecule
Partner/Sponsor/Collaborator: Sumitomo Dainippon Pharma Co., Ltd
Deal Size: $21.3 million Upfront Cash: Undisclosed
Deal Type: Agreement July 30, 2020
Details:
Sumitomo Dainippon Pharma has submitted a Japanese New Drug Application (J-NDA) to the Pharmaceuticals and Medical Devices Agency (PMDA) to request approval for the manufacturing and marketing of Imeglimin for the treatment of type 2 diabetes.
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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): 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.