Tharimmune, Inc. announced initiation of a Phase 1 trial with TH104, utilizing a proprietary oral thin film. TH104 is a proprietary transmucosal buccal film embedded with the active compound nalmefene onto a thin film which easily adheres inside of the mouth on the cheek and biodegrades within minutes. This provides key features making TH104 an ideal product candidate for multiple liver-related and other pruritogenic inflammatory conditions.

The molecule has a dual mechanism of action affecting both the u-opioid and kappa opioid receptors with emerging data showing inhibition of interleukin-17, a pro-inflammatory cytokine. These well-known opioid receptors when stimulated and/or inhibited by the body's endogenous ligands have been shown to be involved in the body's itch circuit for certain conditions, including cholestatic or dysregulated bile acid-related liver conditions. The Phase 1 clinical trial currently recruiting is a pharmacokinetic bridging study in the U.S. designed as a single-dose, single-center, open-label, randomized 2-way crossover study of TH104 and an intravenous dose of nalmefene administered under fasting conditions, with a 7-day washout period between doses.

Sixteen normal healthy volunteers are anticipated to participate and complete the study. The primary objective is to evaluate the absolute bioavailability of TH104 as well as assess safety and tolerability. Topline data is expected in second quarter 24 with a full data readout shortly thereafter.

Safety and tolerability correlated with previous studies consistent in the literature with nalmefene, the active ingredient in TH104. Tharimmune is advancing TH-3215 designed as a bispecific antibody (BsAb) targeting the extracellular domains of HER2 and HER3. These validated targets have been extensively studied and belong to the ERBB receptor tyrosine kinase family and are exploited by cancer cells to promote tumorigenesis and metastasis.

Tharimmune aims to develop both TH-3215 and TH-1940 using this framework to exchange antigen-recognition sites designed to fit distinct portions of the HER2/HER3 heterodimer complex and other validated cancer targets, such as programmed cell death protein 1 or PD-1 potentially effecting both ligand-dependent and independent signaling pathways into tumor cells. The Company announced in 4Q23 the closing of an $11 million public offering which it believes is sufficient to extend its cash runway into early 2025 for both clinical readouts of its lead program, TH104. Tharimmune plans to advance both its clinical and non-clinical programs and announce an R&D Day in 2Q24 to update stakeholders and patients.