TFF Pharmaceuticals Provides Continued Positive Outcomes from Tacrolimus Inhalation Powder (TFF TAC) Phase 2 Trial for the Prevention of Lung Transplant Rejection

Core Insights - TFF Pharmaceuticals is advancing its Phase 2 trial of Tacrolimus Inhalation Powder (TFF TAC) for lung transplant rejection prevention, with 13 patients now enrolled and showing promising results [1][3][4] Patient Enrollment and Treatment Outcomes - Patient enrollment has accelerated, with 13 patients currently in the trial [1][3] - TFF TAC, administered at approximately 20% of the oral tacrolimus dose, has prevented acute rejection and achieved over 80% of previous oral trough blood levels, leading to a reduced drug burden [1][3] - 100% of patients who completed the 12-week treatment opted to continue with TFF TAC in the long-term extension phase [1][3] - Total patient exposure to TFF TAC therapy has reached 2,063 days, equivalent to 5.65 years [3] Biomarker and Efficacy Data - A 6.5-fold reduction in the number of abnormally expressed rejection-related gene sets was observed after 12 weeks of treatment with TFF TAC [4][9] - No production of donor-specific antibodies (DSA) was detected in the first 8 patients, indicating sufficient systemic immune suppression [5][9] - The expression of rejection-related genes decreased from 23% to 4%, representing an 85% reduction [4] Safety and Tolerability - There have been no reported mortalities, and the majority of treatment-emergent adverse events were Grade 2 or lower [6] - No bronchospasm or wheezing was reported, and kidney function has been maintained [6] - One patient experienced acute rejection symptoms due to a dose that was too low, but this was resolved upon resuming oral tacrolimus [7] Future Plans and Regulatory Communication - The company is finalizing the design of the next study in collaboration with clinical investigators and regulatory authorities, with updates expected later in the fall [2][8]