BRIDGEWATER, NJ - Tharimmune, Inc. (NASDAQ:THAR), a biotechnology firm focusing on inflammation and immunology treatments, has announced the completion of a Phase 1 clinical trial for its drug candidate TH104. The trial assessed the safety and bioavailability of TH104, a transmucosal buccal film embedded with nalmefene, designed to bypass liver metabolism, potentially benefiting patients with liver-related and pruritogenic inflammatory conditions.
The study, which was conducted in the United States, compared TH104 to an FDA-approved intravenous formulation of nalmefene. Preliminary results indicated that TH104 has a safety and tolerability profile comparable to the intravenous reference drug, with mild side effects such as nausea, dizziness, and drowsiness that were self-resolving.
Twenty volunteers participated in the study, with 19 completing it. The primary goal was to evaluate the absolute bioavailability of TH104 and assess its safety and tolerability. The pharmacokinetic analysis of the Phase 1 trial is ongoing, with top-line data expected in the second quarter of 2024.
Tharimmune's CEO, Randy Milby, expressed satisfaction with the trial's completion, indicating that the data are crucial for advancing to the Phase 2 program slated to begin this year. The company is targeting moderate-to-severe chronic pruritus in primary biliary cholangitis (PBC), a chronic autoimmune disease that frequently causes pruritus, which is often under-treated.
The company previously reported consistent and predictable delivery of nalmefene in healthy subjects using TH104 in ex-US human studies. Additionally, an open-label trial in patients with cholestatic liver disease showed a significant reduction in itch intensity following a single low dose of TH104.
Last quarter, Tharimmune closed an $11M public offering, which is expected to fund the company into early 2025. Plans are underway to advance clinical and non-clinical programs and provide an R&D update in the second quarter of 2024.
TH104's dual mechanism of action targets the mu and kappa opioid receptors, which are implicated in the body's itch circuitry, particularly in conditions like PBC. Pruritus in PBC affects a substantial proportion of patients and impacts their quality of life, highlighting the need for effective treatment options.
This news is based on a press release statement from Tharimmune, Inc. and does not constitute an endorsement of the company or its products.
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