Tharimmune Reveals Favorable Outcomes from TH104's Phase 1 Clinical Evaluation

Tharimmune, Inc. has successfully completed a Phase 1 clinical trial for TH104, a transmucosal buccal film containing nalmefene, which is well-tolerated with mild side effects. The study compared TH104's oral transmucosal delivery to an injectable form of the drug and demonstrated similar safety profiles. The company is financially prepared through 2025 and is on schedule to start a Phase 2 study for moderate-to-severe chronic pruritus in primary biliary cholangitis (PBC) patients in 2024.
TH104 is designed to bypass the liver's first-pass metabolism and targets the mu and kappa opioid receptors, which are involved in the body's itch response, particularly in cholestatic liver conditions. The Phase 1 trial was a single-dose, open-label study with 20 healthy volunteers, and the primary goal was to assess bioavailability, safety, and tolerability. The results are expected in Q2 2024.
Preliminary safety analysis showed that all adverse events were mild and evenly distributed between TH104 and the injectable drug. No serious adverse events were reported. Tharimmune's CEO, Randy Milby, expressed satisfaction with the results and thanked the participants.
PBC is a chronic autoimmune disease characterized by symptoms like severe itching and fatigue. Current treatments for PBC-related pruritus are often ineffective or poorly tolerated, highlighting the need for new solutions. TH104 has shown potential in reducing itch intensity in a previous study with cholestatic liver disease patients.
Tharimmune recently closed an $11 million public offering, which is expected to fund the company's operations into early 2025. The company plans to advance its clinical and non-clinical programs and will hold an R&D Day in Q2 2024 to update stakeholders.
TH104 is a buccal film that delivers nalmefene, targeting opioid receptors involved in itch response. PBC is a chronic liver disease that predominantly affects women and has limited treatment options for its associated severe itching. Tharimmune is a clinical-stage biotechnology company focused on developing therapeutic candidates for inflammatory and immunological conditions, with TH104 as its lead asset for treating pruritus in PBC. The company also has a pipeline of immunology treatments targeting solid tumors.

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