Tharimmune announces positive Phase 1 results for TH104 and funding until 2025

Tharimmune, Inc., a clinical-stage biotechnology company, has completed its Phase 1 clinical trial with TH104, targeting inflammatory pruritic and hepatic conditions. TH104, a transmucosal buccal film containing nalmefene, has shown a tolerability profile comparable to its approved intravenous reference, according to preliminary results. The study involved 20 healthy volunteers, with 19 completing the protocol. Reported side effects were mild and self-resolving, consistent with prior studies and literature on nalmefene.

Tharimmune's next goal is to initiate a Phase 2 study for moderate to severe chronic pruritus in primary biliary cholangitis (PBC) in 2024. PBC, a chronic autoimmune cholestatic liver disease, causes "unbearable itch" and fatigue severely impacting quality of life, with a pressing need for effective solutions.

Having completed a public offering of $11 million last quarter, Tharimmune states it is financially secure until early 2025 for its clinical programs' outcomes, including TH104. The company also plans an R&D day in the second quarter of 2024 to provide updates to stakeholders.