Tharimmune Announces Positive Type C Meeting with FDA for Phase 2 Program for TH104

Tharimmune, Inc. (Nasdaq:THAR), a clinical-stage biotechnology company, has received positive feedback from the U.S. Food and Drug Administration (FDA) regarding its Phase 2 trial for TH104. The program focuses on treating moderate-to-severe pruritus in primary biliary cholangitis (PBC), a rare liver disease with no known cure.

CEO Randy Milby expressed satisfaction with the FDA's feedback, which supports the company's plan to pursue a 505(b)(2) approval pathway for TH104. The FDA's approval confirms that the nonclinical studies submitted appear adequate for advancing to the Phase 2 trial. Additionally, the FDA provided guidance on study design and patient inclusion criteria.

Based on the FDA's feedback, Tharimmune is on track to initiate the Phase 2 trial later in 2024. The company is now incorporating the FDA's recommendations into its clinical protocol.