Tharimmune Inc’s stock witnessed a notable surge in trading as the biotechnology company unveiled promising results from its Phase 1 trial of TH104, a groundbreaking proprietary transmucosal buccal film. The trial, a crossover study involving 12 healthy volunteers under fasting conditions, compared TH104’s transmucosal buccal film with a tablet formulation available in Europe but not in the U.S.
At the time of this publication, Tharimmune Inc stock (THAR) has witnessed a surge.
Tharimmune Inc
Current Price: $3.91
Change : +1.03
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The primary focus of the Phase 1 trial was to assess the pharmacokinetics of TH104, with secondary objectives including determining its relative bioavailability and evaluating tolerability for potential use in clinical efficacy studies. The trial results indicated that the pharmacokinetic evaluation of TH104’s transmucosal film, administered at an equal-labeled dose as the European tablet, was consistent and comparable to existing literature.
Remarkably, the observed Cmax and AUC0-∞ of TH104 were higher than those of the tablet, suggesting a potential advantage for patients with impaired liver function due to reduced presystemic metabolism in the lower GI and liver. However, the half-life and Tmax remained similar for both formulations, with no reported deaths, serious adverse events, or significant adverse events.
Building on this success, Tharimmune Inc conducted a second Phase 1 study involving two treatment groups with different formulations of TH104, varying in pH, and sixteen healthy volunteers under fasting conditions. The primary focus of this study was to assess the impact of pH in the transmucosal buccal film on drug absorption profiles, evaluated through serial blood sample collections.
Results from the second Phase 1 study indicated that variations in pH had an insignificant effect on TH104’s performance, measured by drug concentrations in human plasma. This finding suggests that inter-patient variability in oral pH is unlikely to significantly impact drug absorption, promising predictability in terms of delivery speed and drug action in the systemic circulation. Importantly, no new adverse events were reported during the entire study, and the safety profile remained consistent with existing literature.
Buoyed by these positive results, Tharimmune Inc now sets its sights on engaging with the FDA to design Phase 2 trials. The company anticipates topline data for chronic pruritus in primary biliary cholangitis (PBC) patients in 2024. Tharimmune Inc’s breakthrough with TH104’s transmucosal buccal film not only propels the company forward in the biotechnology sector but also instills confidence among investors, reflected in the recent surge in stock prices. The successful Phase 1 trials pave the way for further advancements in the development of innovative treatments, holding the potential to transform the landscape of patient care and treatment options.
