Tharimmune sees TH023 as pioneering oral antibody delivery

The company said, “The administration of monoclonal antibodies, while highly effective for a range of chronic diseases, has historically been limited to intravenous infusions or subcutaneous injections. These parenteral routes often necessitate frequent clinic visits, specialized medical personnel for administration, and can be painful or inconvenient for patients, impacting adherence to long-term therapy. The development of an effective oral delivery method for antibodies would truly be a “game-changer,” revolutionizing patient access, convenience, and quality of life by transforming a complex, clinic-bound procedure into a simple, at-home pill. Overcoming the formidable physiological barriers of the gastrointestinal tract – including harsh pH environments, enzymatic degradation, and limited permeability for large molecules – has been a persistent challenge in biopharmaceutical development. We believe Tharimmune’s (THAR) TH023 program is at the forefront of addressing this critical unmet need.Tharimmune is developing TH023, a novel oral monoclonal antibody targeting Tumor Necrosis Factor-alpha, licensed through Intract Pharma, which could potentially revolutionize the delivery of biologic therapies for a wide array of inflammatory conditions. In an advancement for oral antibody delivery, Tharimmune in the past year announced positive preclinical results for TH023. Leveraging a proprietary protease enzyme stabilized platform preclinical studies in a murine model successfully demonstrated oral delivery of infliximab, achieving serum concentrations significantly higher than standard therapeutic levels. The studies confirmed enzymatic protection and successful in vivo delivery to both local colonic tissue and systemic circulation, highlighting its potential for treating both local gastrointestinal diseases and systemic inflammatory conditions. This proprietary formulation showed superior tissue penetration compared to traditional permeation enhancers, underscoring the innovative nature of TH023.This program originated from a strategic global licensing agreement with Intract Pharma for INT-023 in September 2024. Traditionally, TNF-alpha inhibitors like infliximab are administered via intravenous infusions or subcutaneous injections, which may be burdensome for patients. TH023 aims to overcome these challenges, offering a convenient oral pill form that could dramatically improve patient compliance, quality of life, and reduce healthcare system burdens. With the global infliximab market in the multibillions, an oral formulation represents a substantial commercial opportunity by providing a differentiated, patient-preferred option that broadens access and potentially lowers overall treatment costs. Building on these promising preclinical results, Tharimmune plans to optimize TH023’s formulation and dosing regimen and prepare for a first-in-human clinical trial within the next 12 months, marking a significant step towards bringing this transformative therapy to patients.”