Tharimmune's Oral 'Under The Cheek' Candidate At Par With FDA-Approved Injectable With Potential For Chronic Liver Disease

Tuesday, Tharimmune Inc THAR completed its Phase 1 clinical trial with TH104, a proprietary transmucosal buccal film embedded with the approved, active compound nalmefene, which easily adheres inside of the mouth on the cheek and biodegrades within minutes. 

TH104 is designed to avoid the liver’s first-pass metabolism seen in oral formulations and may be an ideal product candidate for multiple liver-related and other pruritogenic inflammatory conditions. 

The completed Phase 1 trial was a pharmacokinetic bridging study in the U.S. and was designed as a single-dose, single-center, open-label, randomized 2-way crossover study with 16 mg of TH104 compared to an intravenous 1 mg dose of nalmefene administered under fasting conditions, with a 7-day washout period between doses. 

Twenty healthy volunteers participated, and 19 subjects completed the study. The Phase 1 pharmacokinetic analysis is ongoing, and the topline readout and full data are expected to be achieved in the second quarter of 2024.

The Phase 1 study demonstrated that TH104 had a safety and tolerability profile comparable to the drug’s FDA-approved nalmefene reference intravenous formulation. 

In the preliminary analysis of the completed trial safety results, all adverse events reported in the clinical trial were categorized as mild and were evenly reported between TH104 and intravenous injection. 

No deaths, serious adverse events, or other significant adverse events were reported.

Last quarter, Tharimmune announced the closing of an $11 million public offering, which it believes is sufficient to extend its cash runway into early 2025 for clinical readouts of its lead program, TH104. 

The company plans to advance its clinical and non-clinical programs and announce an R&D Day in the second quarter of 2024.

Price Action: THAR shares are up 0.26% at $0.39 on the last check Tuesday.