Tharimmune Reveals Phase 2 Study Plan for TH104 in Primary Biliary Cholangitis Pruritus and Shares Business Update

BRIDGEWATER, NJ / ACCESSWIRE / December 16, 2024 / Tharimmune, Inc. (Nasdaq:THAR), a clinical-stage biotechnology enterprise, has unveiled its plans to commence a Phase 2 clinical trial evaluating TH104's efficacy in treating moderate-to-severe pruritus linked with primary biliary cholangitis (PBC). PBC is a rare, chronic liver condition. This announcement follows the successful completion of a Phase 1 study of TH104, regulatory feedback from both the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA), and advancements in the production of clinical study supplies. The trial is expected to begin in 2025.

### Progress and Achievements in 2024

Throughout the year, Tharimmune reached noteworthy milestones in three primary areas, emphasizing its commitment to innovation in therapies targeting inflammation and immunology. This progress is pivotal in enhancing patient outcomes in areas with significant unmet medical needs.

#### Manufacturing and Regulatory Advancements

The company is on schedule to validate and produce the necessary TH104 supplies for the Phase 2 clinical trial by the year's end. The Phase 1 trial yielded positive results, showing a favorable pharmacokinetic profile and a mild side-effect profile in healthy participants. This led to constructive regulatory guidance from the FDA and EMA for the Phase 2 trial design. Additionally, Tharimmune secured a patent from the European Patent Office for a novel therapeutic platform addressing stability and absorption challenges in antibody and peptide treatments.

#### Engagement with the Medical Community

Tharimmune actively participated in key industry conferences, sharing promising clinical data with the scientific community. At the American College of Gastroenterology (ACG) Annual Scientific Meeting, Tharimmune presented data reinforcing the safety of TH104 with no unexpected adverse events. Further, at the American Association for the Study of Liver Diseases (AASLD) meeting, Tharimmune highlighted the correlation between blood levels and symptom relief in patients treated with TH104.

#### Corporate Developments

The company entered into licensing agreements with Intract Pharma to develop oral biologics, including an oral infliximab formulation, and with OmniAb for antibody discovery technology. Tharimmune appointed David Jones, an expert in liver immunology, to its Scientific Advisory Board. Additionally, the company raised more than $4 million through private placements to support the TH104 program and other developments.

### Phase 2 Clinical Study for TH104

The upcoming Phase 2 trial is a multicenter, randomized, double-blind, placebo-controlled study aimed at evaluating the safety, tolerability, and effectiveness of TH104 in PBC patients suffering from pruritus. This condition severely impacts daily life and represents a high unmet medical need. The trial will enroll approximately 40 participants across sites in the U.S., Europe, and the UK. Patients will receive escalating doses of TH104 over nine weeks, with efficacy assessed through changes in patient-reported itch scores and other quality-of-life metrics.

### Board of Directors Expansion

Tharimmune announced the appointment of Sanam Parikh to its Board of Directors, bringing the total to six directors. Mr. Parikh's experience in managing clinical trials and regulatory submissions will be invaluable to Tharimmune. His role will enhance the company’s operations, particularly in trial execution and regulatory compliance.

### About TH104 and Pruritus

TH104 is designed with nalmefene on a transdermal buccal film for easy adhesion within the mouth. This product candidate targets liver-related and other inflammatory conditions, working on both the µ-opioid and kappa-opioid receptors, and potentially inhibiting IL-17 inflammatory cytokines. This dual mechanism may play a role in managing the body’s itch response.

PBC causes significant liver damage due to dysfunctional bile ducts, and pruritus affects up to 75% of PBC patients. The chronic itching, often worse at night, greatly diminishes quality of life, highlighting the need for effective treatments.

### About Tharimmune

Tharimmune is devoted to developing therapies targeting immunology, inflammation, and oncology. Its flagship clinical candidate, TH104, aims to alleviate chronic pruritus associated with PBC. The company is also exploring other therapeutic avenues, including TH023 for autoimmune diseases. Collaborations with firms like OmniAb bolster its innovative approaches in targeting disease markers.