Tharimmune presents TH104 Phase 1 data at ACG Annual Meeting

Tharimmune (THAR) presented new TH104 Phase 1 data at the American College of Gastroenterology 2024 Annual Scientific Meeting, underway in Philadelphia. The Phase 1 trial was a single-dose, single-center, open-label, randomized study of TH104 transmucosal buccal film conducted in two cohorts of patients with chronic liver disease. The primary outcome measure was to determine the safety and tolerability of a single buccal dose of TH104 in these patients. The data presented included adverse events as well as assessment of patients using the Clinical Opiate Withdrawal Scale. The COWS is an 11-item clinician-administered scale that can be used in both inpatient and outpatient settings to reproducibly rate common signs and symptoms of opiate withdrawal and monitor them over time. The summed score for the complete scale can be used by clinicians to determine the stage or severity of withdrawal, and to assess the level of any physical dependence. This study enrolled two types of CLD patients categorized as Child-Pugh A and Child-Pugh B. The Child-Pugh score is a system for assessing the prognosis and necessity of transplant in CLD that provides a forecast of the increasing severity of a patient’s liver disease and expected survival rate. The score is determined by scoring clinical measures of liver disease and the possibility of eventual liver failure, with Class A indicating mild liver disease and Class B indicating moderate liver disease with a one-to-five-year survival rates of 95% and 75%, respectively. There were no patients enrolled in this study with the most severe Child-Pugh C classification. The mean baseline WI-NRS scores in Groups A and B were 4.33 and 6.17, respectively, translating to moderate-to-severe chronic pruritus at the start of the study. The mean baseline itch score for all 12 subjects was 5.25. At one hour post-dosing with TH104, Group A and Group B had a mean decline in WI-NRS scores of 26.8% and 19.0%, respectively, and continued to decline two hours post-dose by 42.3% and 21.7%, respectively. Both cohorts continued to improve in mean itch scores at the four-hour and eight-hour time points, including the combined total subjects. At 24-hours post dosing, Group A and Group B achieved a mean decline of 30.7% and 35.2%, respectively, in pruritus scores. The mean reduction in itch scores for all 12 subjects 24 hours after a single dose of TH104 was 33.3%. There were no deaths, other serious adverse events or other significant adverse events reported during the entire study. There were no new adverse events during the entire study, with events correlated with previous studies and a safety profile consistent with the literature for the active ingredient in TH104. The Company plans to initiate a Phase 2 multiple-ascending dose trial in the coming months to assess the safety and tolerability of TH104, which will assess the change from baseline in WI-NRS scores to evaluate chronic pruritus in PBC patients. The Company expects topline data in 2025 and is engaging with both U.S. and EU regulatory authorities.