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Lead Product(s): Budesonide
Therapeutic Area: Immunology Product Name: Nefecon
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 January 21, 2021
Details:
The NefIgArd trial consists of two parts: Part A and Part B. Part A, which forms the basis for potential regulatory submissions and approvals, provided data on the efficacy and safety of Nefecon.
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Lead Product(s): Budesonide
Therapeutic Area: Immunology Product Name: Nefecon
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 November 08, 2020
Details:
The trial met its primary objective of demonstrating a statistically significant reduction in urine protein creatinine ratio, UPCR or proteinuria, after 9 months of treatment with 16 mg of Nefecon compared to placebo, with significant continued improvement at 12 months.
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Lead Product(s): Budesonide
Therapeutic Area: Immunology Product Name: Nefecon
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 October 19, 2020
Details:
The poster describes the design of the NefIgArd trial, which is exploring the effect of Nefecon in patients with IgA Nephropathy (IgAN) who are at risk of developing End Stage Renal Disease.
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Lead Product(s): Budesonide
Therapeutic Area: Immunology Product Name: Nefecon
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 08, 2020
Details:
Following IND approval by the NMPA in December of 2019 and subsequent approval by Human Genetic Resources Administration of China (HGRAC), the first patient in China has now been randomized in the Phase 3 NefIgArd trial.
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Lead Product(s): Budesonide
Therapeutic Area: Immunology Product Name: Nefecon
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 April 27, 2020
Details:
Calliditas does not anticipate a significant impact of the Covid-19 pandemic on the ongoing clinical activities related to NefIgArd, the company's pivotal Phase 3 IgA nephropathy trial.
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