COUR Pharmaceuticals, a biotechnology company, announce on Monday that the United States Food and Drug Administration (FDA) has granted Fast Track Designation to the firm's investigational therapy CNP-104 to treat Primary Biliary Cholangitis (PBC), a liver disease that can get worse over time.
The product is intended to reprogram the immune system to address the autoimmune causes of PBC.
The US FDA accepted the company's investigational new drug application (IND) for the product in October 2021. Presently, the company is opening the first human dosing in a proof-of-concept (Phase 2) study for CNP-104 (NCT05104853) in early 2022 to assess the safety, tolerability, pharmacodynamics and efficacy of the therapy in PBC patients.
Fast Track Designation is an FDA process designed to facilitate the development and review of potential therapies that seek to fill an unmet medical need.
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