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Calliditas Therapeutics AB (symbol: CALTX) is a biopharmaceutical company based in Stockholm, Sweden, dedicated to identifying, developing, and commercializing innovative treatments for rare diseases with unmet medical needs. The company recently announced positive results from the Phase 2 trial evaluating setanaxib, its lead NOX enzyme inhibitor, in combination with pembrolizumab for squamous cell carcinoma of the head and neck. The trial demonstrated statistically significant improvements in progression-free survival and overall survival, along with changes in tumor biology supporting the mechanism of action of setanaxib. Calliditas is also engaged in ongoing clinical trials in other indications, such as primary biliary cholangitis and idiopathic pulmonary fibrosis, showing promising results. The company focuses on anti-fibrotic effects and the development of its first-in-class NOX platform.
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Calliditas Therapeutics presented additional data analyses from the Phase 3 NefIgArd study at the American Society of Nephrology Kidney Week 2023. The study evaluated Nefecon in adults with primary IgA nephropathy and showed a delayed progression to a 30% eGFR reduction compared to placebo. Nefecon also resulted in lower deterioration in renal function, reduced urine protein creatinine ratio, and decreased microhematuria. Serum biomarker analysis demonstrated a disease-modifying effect of Nefecon. Modeling analysis predicted a substantial delay in renal failure progression. Setanaxib, a dual NOX inhibitor, showed promising results in reducing fibrosis and glomerular sclerosis in a mouse model of Alport syndrome.
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Calliditas Therapeutics announces approval of Nefecon in Macau for the treatment of IgA nephropathy
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Calliditas Therapeutics announces abstract presentations at upcoming American Society of Nephrology Kidney Week 2023
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Calliditas receives positive opinion for orphan drug designation for setanaxib in Alport syndrome from European Medicines Agency
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Everest Medicines' partner, Calliditas Therapeutics, presented positive findings from biomarker and patient subgroup analyses of Nefecon®'s Phase 3 NefIgArd study. The treatment showed a decrease in IgA-IC levels and modulation of the intestinal immune network. It also demonstrated preservation of kidney function in Asian and White patients with IgAN.
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Calliditas Therapeutics announced positive findings from biomarker and subgroup analyses of Phase 3 NefIgArd study with Nefecon in adults with IgA nephropathy. Nefecon treatment resulted in a decrease in IgA-containing immune complexes levels and modulation of immune abnormalities. Levels of BAFF, APRIL, and sBCMA were decreased, indicating a disease-modifying effect. Treatment with Nefecon preserved kidney function in both Asian and White patients. Nefecon showed significant benefits in eGFR, proteinuria reduction, and decrease in microhematuria. TARPEYO is indicated to reduce proteinuria in adults with IgAN. Important safety information provided.
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STADA and Calliditas submit request to EMA to convert conditional marketing authorization for Kinpeygo treatment for primary IgA nephropathy to standard marketing authorization. Kinpeygo is the first approved treatment in Europe for IgAN. Submission based on full two-year data set from Phase 3 NefIgArd trial. Positive results showed significant benefit in estimated glomerular filtration rate. Companies optimistic about bringing therapy to more patients in Europe.
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The FDA grants orphan drug designation to Calliditas Therapeutics for the treatment of Alport syndrome with setanaxib, prompting plans for a phase 2 clinical study. Alport syndrome affects 30,000 to 60,000 people in the US and is a significant cause of chronic kidney disease. Positive for Calliditas stock.
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Calliditas Therapeutics announces upcoming data presentations from the NeflgArd Phase 3 Study at the 17th International Symposium on IgA Nephropathy (IIgANN).
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Everest Medicines announces FDA acceptance of sNDA for Nefecon® with Priority Review, expected decision on Dec. 20, 2023. Positive trial data shows significant eGFR treatment benefit and potential to delay dialysis for IgAN patients. NDA decision in China expected in H2 2023.
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FAQ
What is Calliditas Therapeutics AB focused on?
Calliditas is dedicated to identifying, developing, and commercializing novel treatments for orphan indications with significant unmet medical needs.
What recent trial results did Calliditas announce?
Recent results from the Phase 2 trial of setanaxib in combination with pembrolizumab for squamous cell carcinoma of the head and neck showed statistically significant improvements in progression-free survival and overall survival, supporting the drug's mechanism of action.
What other clinical trials is Calliditas conducting?
The company has ongoing clinical trials for primary biliary cholangitis, idiopathic pulmonary fibrosis, and Alport syndrome, with expected data readouts in the near future.
What is the focus of Calliditas' research and development efforts?
Calliditas emphasizes anti-fibrotic effects and is advancing its first-in-class NOX platform, demonstrating positive clinical evidence in targeted indications.
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