Tharimmune Launches TH104 Phase 1 Trial and Business Update

Tharimmune, a biotechnology firm focused on inflammation and immunology, has commenced a Phase 1 clinical trial for its product candidate TH104. The trial is designed to evaluate the safety, tolerability, and absolute bioavailability of TH104, which is administered through a proprietary oral thin film containing the active ingredient nalmefene. This transmucosal buccal film is applied inside the mouth and degrades rapidly, offering a promising approach for treating various liver-related and inflammatory conditions characterized by pruritus.

The Phase 1 study is a pharmacokinetic bridging trial, involving a single dose given to healthy volunteers. It aims to compare TH104 with an intravenous dose of nalmefene, with results expected in the second quarter of 2024. TH104 operates through a dual mechanism, targeting both µ-opioid and kappa opioid receptors, and has shown potential in inhibiting interleukin-17, a cytokine linked to inflammation.

In addition to the Phase 1 trial, Tharimmune is planning a Phase 2 study for 2024, which will focus on the effects of TH104 on moderate-to-severe chronic pruritus in patients with primary biliary cholangitis (PBC). The company intends to consult with U.S. and European regulatory authorities to align on the trial's design. The results from this study are expected to provide valuable insights into TH104's efficacy in treating pruritus, a common symptom in liver diseases, particularly PBC.

Tharimmune's pipeline also includes TH-3215, a bispecific antibody targeting HER2 and HER3, which are known to play a role in cancer development. The company is also developing Picobodies, which are derived from bovine antibodies and offer a unique approach to accessing previously hidden epitopes on cancer targets.

The company has secured funding through a public offering, which it believes will support its operations and the advancement of its clinical programs through to 2025. Tharimmune is committed to keeping stakeholders informed and plans to hold an R&D day in 2024 to provide updates on its progress.

CEO Randy Milby expressed satisfaction with the progress made, highlighting the potential of TH104 to offer a new treatment strategy for chronic pruritus in PBC. The company is focused on transforming into a clinical entity and engaging with shareholders, patients, and stakeholders on its pipeline development.

TH104 is a unique product candidate with a dual mechanism of action that could be beneficial for patients suffering from pruritus associated with liver diseases. PBC, an autoimmune disease affecting the liver's bile ducts, is particularly noted for causing severe pruritus, which can significantly impact patients' quality of life. Tharimmune's commitment to advancing treatments for this condition is a step towards addressing a significant unmet need.

Tharimmune is dedicated to developing innovative therapeutics for inflammatory and immunological conditions. With a robust pipeline that includes multi-specific antibodies and novel antibody technologies, the company is poised to make significant contributions to the field of medicine.