Tharimmune Announces Positive FDA Type C Meeting for Phase 2 TH104 Program in Pruritus

Tharimmune, Inc., a biotechnology company focusing on treatments for inflammation and immunology, has reported favorable feedback from the U.S. Food and Drug Administration (FDA) regarding its Phase 2 clinical trial for TH104. This drug is a buccal film embedded with nalmefene, aimed at treating moderate-to-severe pruritus in primary biliary cholangitis (PBC), a rare liver disease.

CEO Randy Milby expressed satisfaction with the FDA's feedback, indicating excitement about advancing TH104's development. TH104 is designed to bypass the liver's first-pass metabolism, making it potentially suitable for liver-related and pruritogenic conditions. The drug operates through a dual mechanism affecting mu (μ-) and kappa opioid receptors, which are implicated in the body's itch circuitry, particularly in cholestatic liver conditions.

The FDA's Type C meeting feedback confirmed Tharimmune's plan to seek a 505(b)(2) approval pathway for TH104, which allows for the inclusion of data from external studies when the active ingredient is already approved. The FDA also agreed that the nonclinical studies provided are sufficient to support the proposed Phase 2 trial. Additionally, the FDA offered recommendations on study design, patient inclusion criteria, primary endpoints to assess pruritus, and monitoring for adverse events.

Tharimmune believes this feedback provides a clear path to initiating a Phase 2 trial for TH104 in PBC patients with moderate-to-severe pruritus. The company is currently integrating the FDA's feedback into the clinical protocol and expects to begin the trial in late 2024.

TH104 stands out due to its transmucosal buccal film delivery system, which adheres to the inside of the mouth. This form allows for efficient absorption and effectiveness in treating liver-related and pruritogenic conditions. The dual mechanism of action, targeting both μ-opioid and kappa opioid receptors, is crucial for its role in addressing itch circuitry in the body.

Tharimmune, Inc. is dedicated to developing therapeutic candidates for inflammation and immunology. TH104 is its leading clinical-stage asset, showing promise in reducing chronic pruritus in PBC, a disease with no known cure. The company also has an early-stage immunology pipeline, featuring multi-specific antibodies targeting unique epitopes with novel mechanisms against validated targets in multiple solid tumors, including PD-1, HER2, and HER3. Tharimmune has a license agreement with OmniAb, Inc., providing access to OmniAb's antibody discovery technology platform for these and other targets.