Tharimmune’s buccal film liver drug exhibits efficacy in Phase I trial

Tharimmune, a US biotech firm, has unveiled promising data on TH104, a transmucosal buccal film designed for liver-related and inflammatory conditions. TH104 targets ailments like primary biliary cholangitis. In a Phase I trial involving 20 healthy volunteers, participants received either 16mg of TH104 or a 1mg dose of nalmefene, its active ingredient. The trial met its primary endpoint, assessing bioavailability, safety, and efficacy, with only mild adverse events reported. Ongoing Phase I pharmacokinetic analysis is expected to conclude by Q2 2024.

The buccal film, a dissolvable strip placed inside the mouth, delivers medication through oral mucous membranes, bypassing the digestive system for rapid absorption into the bloodstream. Tharimmune recently closed an $11 million public offering to advance TH104 into Phase II trials for chronic pruritus in primary biliary cholangitis. PBC, an autoimmune liver disease, causes scarring and impaired liver function due to the immune system's attack on bile ducts.