Why Is Liver Disease Focused Tharimmune Stock Trading Higher Today?

Tharimmune Inc THAR released phase 1 data with TH104, a proprietary transmucosal buccal film. 

The first Phase 1 trial was a crossover study of TH104 transmucosal buccal film compared to a tablet formulation marketed in Europe and not the U.S., with a 14-day washout involving 12 healthy volunteers under fasting conditions. 

The primary outcome measure was to determine the pharmacokinetics of a buccal dose of TH104, while secondary objectives included establishing the relative bioavailability of TH104 and evaluating its' tolerability for potential value in clinical efficacy studies.

In this study, the pharmacokinetic evaluation of TH104 transmucosal film compared to an oral tablet marketed in Europe but not the U.S., given as an equal-labeled dose in healthy volunteers under fasting conditions, was consistent and similar in comparison with results from the literature. 

The Cmax and AUC0-∞ of TH104 were observed to be higher than the tablet product because of a possible reduced presystemic metabolism in the lower GI and liver, which is potentially advantageous for patients with an impaired liver. 

The half-life and Tmax were observed to be similar for both products. No deaths, other serious adverse events, or other significant adverse events were reported.

The second phase 1 study was with two treatment groups of 2 different formulations of TH104 with variable pH in sixteen healthy volunteers under fasting conditions. The primary outcome measure was to determine the effect of pH in the transmucosal buccal film on the drug absorption profile evaluated from serial blood sample collections.

In this study, the evaluation of TH104 transmucosal film given as an equal-labeled dose in 2 different pH formulations delivered buccally to healthy volunteers under fasting conditions had an insignificant effect on the film's performance as measured by drug concentrations in human plasma. 

The low impact on pH shows that variations of oral pH due to inter-patient variability in future studies would have a low impact on predictable drug absorption regarding speed of delivery and drug action once absorbed into the systemic circulation. 

There were no new adverse events during the entire study, with events correlated with the previous study and a safety profile consistent with the literature.

The company expects to engage the FDA on Phase 2 trial design and expects topline data in 2024 for chronic pruritis in primary biliary cholangitis (PBC) patients.

Price Action: THAR shares are up 50% at $4.32 on the last check Monday.