Tharimmune Initiates Phase 1 Trial with TH104 for Treating Itch in Primary Biliary Cholangitis

The first individual has been administered TH104 in a Phase 1 clinical trial, focusing on the drug's safety, tolerability, and absolute bioavailability. Tharimmune, Inc., a biotech firm specializing in inflammation and immunology treatments, is using an innovative oral thin film delivery system for the compound nalmefene in this trial. The study is anticipated to conclude in the first quarter of 2024, with preliminary results to be shared in the second quarter of the same year. TH104 is being developed for liver-related and other inflammatory conditions that cause itching, and it operates by targeting specific opioid receptors and potentially inhibiting interleukin-17. The current trial is a single-center, open-label, randomized crossover design involving a single dose of TH104 and an intravenous nalmefene dose, with a seven-day interval between doses. It aims to recruit sixteen healthy volunteers. The topline results are expected in the second quarter of 2024, with a comprehensive data release to follow shortly.
Tharimmune's CEO, Randy Milby, highlighted the significance of this milestone in advancing the company's mission to become a patient-centric clinical development entity. TH104 has shown promise in reducing itch intensity in patients with chronic liver disease and has demonstrated safety and tolerability in line with existing literature on nalmefene. The company has secured funding to support its operations and clinical trials through 2025, with plans to initiate a Phase 2 program later this year. TH104's potential to address the unmet need for effective treatments for cholestatic pruritus in patients with primary biliary cholangitis (PBC) is particularly noteworthy. PBC is an autoimmune disease characterized by persistent itching and fatigue, with limited treatment options currently available. Tharimmune is also planning an R&D Day to update stakeholders on its progress in the second quarter of 2024.

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