Calliditas Reports Results from P-IIb (TRANSFORM) Study of Setanaxib for Treating Primary Biliary Cholangitis
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- Calliditas reported topline results from P-IIb (TRANSFORM) study assessing the efficacy of setanaxib 800mg AM + 400mg PM (1200 mg arm) & 800mg BID (1600 mg arm) vs PBO among PBC patients (n=76) with increased liver stiffness
- Study met the 1EP, showing improvement in ALP of 19% (1600mg arm) & 14% (1200mg arm) along with positive trend towards liver stiffness after 24wks. Setanaxib was well-tolerated with similar TEAEs b/w active treatment vs PBO with higher discontinuations in active treatment arm
- In addition, the company is evaluating setanaxib in other trials and anticipates topline data from investigator led P-II IPF study in Q4’24/Q1’25 and from P-II PoC study for Alport syndrome in 2025
Ref: Calliditas | Image: Calliditas
Related News:- Calliditas Therapeutics Launches P-II Trial for Setanaxib in Alport Syndrome
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.