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# FDA Orphan Designation for Biotie Therapies Liver Drug
- URL: https://www.fdaweb.com/fda-orphan-designation-for-biotie-therapies-liver-drug/
- Published: 2016-08-26T12:00:00.000Z
- Updated: 2026-09-14T21:27:11.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5136630

FDA has granted Biotie Therapies an orphan drug designation for its BTT1023 drug candidate for treating primary sclerosing cholangitis (PSC), which is a chronic and progressive fibrotic liver disease for which there are currently no FDA-approved treatments. The company says BTT1023 is a fully human monoclonal antibody targeting Vascular Adhesion Protein -1, and it is currently being studied for PSC in a Phase 2a study (BUTEO study). The two-stage study design includes a pre-planned interim analysis, it says, and based on current enrollment estimates, it expects the analysis will be performed in the first half of 2017.