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FDA Grants Orphan Drug Designation to BTT1023 for PSC
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The FDA granted Biotie Therapies Corporation orphan drug designation for BTT1023 to treat primary sclerosing cholangitis, according to a press release.
BTT1023 is a fully human monoclonal antibody targeting vascular adhesion protein-1 (VAP-1). Presently, there are no FDA-approved treatments for primary sclerosing cholangitis (PSC), according to the manufacturer.
Researchers will use BTT1023 in a Phase 2a study called BUTEO. Biotie planned to conduct an interim analysis of the two phases before it began its’ study; the company presently anticipates enough treated patients in the first half of 2017 to move forward with that analysis.
According to the company’s website, previous clinical studies explored BTT1023’s effectiveness and safety in patients with psoriasis and rheumatoid arthritis. Previous researchers studied the drug in preclinical models of inflammatory diseases such as chronic obstructive pulmonary disease and specific neurological circumstances.
The European Commission granted BTT1023 orphan drug designation in March 2015, according to the release.
Disclosure: Biotie Therapies Corporation reports it received funding from the U.K.’s National Institute for Health Research Efficacy and Mechanism Evaluation Programme.