Tharimmune provides business update, corporate highlights

Throughout 2024 Tharimmune (THAR) achieved significant milestones across three key areas. These accomplishments reflect progress in advancing innovative therapies in inflammation and immunology, with a focus on improving patient outcomes in areas of high unmet need. Manufacturing, Clinical and Regulatory Progress: Validation and batches of manufacturing supply of TH104 for Phase 2 clinical study are on track for year-end. Announced positive results from a Phase 1 clinical trial of TH104 in healthy subjects, demonstrating a favorable pharmacokinetic profile and a mild side-effect profile. Received positive regulatory feedback from the FDA and EMA for the TH104 clinical program, providing guidance on the Phase 2 trial design. Granted a patent from the European Patent Office covering therapeutics created for carrying antibody and peptide therapies, representing a novel solution and addressing critical challenges with stability and absorption. Medical and Scientific Community Engagement: Participated in key industry conferences to present new clinical data and engage with the scientific community. Presented favorable clinical data at the American College of Gastroenterology Annual Scientific Meeting, reinforcing the safety profile of TH104 with no unexpected treatment-emergent adverse events. Shared positive clinical data at the American Association for the Study of Liver Diseases The Liver Meeting, highlighting a significant correlation between blood levels and symptom relief in patients treated with TH104. Corporate Achievements: Entered into a licensing agreement with Intract Pharma, aiming to expand Tharimmune’s product pipeline to develop oral biologics including an oral formulation of infliximab. Entered into a licensing agreement with OmniAb, accessing their antibody discovery technology platform to enhance Tharimmune’s early-stage immunology pipeline. Appointed David Jones, Professor of Liver Immunology at Newcastle University in England and renowned scientist with extensive expertise in hepatic pathologies and PBC, to Tharimmune’s Scientific Advisory Board. Completed private placement financings, raising more than $4 million to support clinical development and working capital, including TH104 development program. The multicenter, randomized, double-blind, placebo-controlled Phase 2 trial is designed to assess the safety, tolerability and efficacy of TH104 in reducing itch in PBC patients with moderate-to-severe pruritus, a condition that significantly impacts daily lives and remains an area of unmet medical need. The study plans to enroll approximately 40 patients at sites in the U.S., Europe and the UK. Patients will receive escalating doses of TH104 in a nine-week study that includes treatment and observation periods, with efficacy measured by changes in patient-reported itch scores utilizing the Worst-Itch Numerical Rating Scale, a relevant clinical outcome assessment for pruritus, as well as other quality-of-life metrics. Additionally, Tharimmune announced the appointment of Sanam Parikh to its Board of Directors, expanding the size of its Board to six Directors. Mr. Parikh brings to Tharimmune significant experience in clinical trial management, regulatory submissions and operational oversight.