TFF Pharmaceuticals announces data from TFF TAC Phase 2 trial

TFF Pharmaceuticals announced additional data from the ongoing Phase 2 study which is evaluating Tacrolimus Inhalation Powder for the prevention of organ rejection in lung transplant recipients. These new data were presented by Professor Gregory Snell, the lead Principal Investigator of the TFF TAC Phase 2 study, in an oral presentation at the International Society for Heart and Lung Transplantation 44th Annual Meeting at a late breaking clinical science abstract session, on April 13, 2024, in Prague, Czech Republic. TFF TAC – updated Phase 2 data post ISHLT 2024 Meeting: The ongoing Phase 2 trial of TFF TAC is an open-label study in lung transplant patients who require reduced tacrolimus blood levels due to kidney toxicity. Part A of the trial is a 12-week treatment period, and Part B is an optional safety extension period. Trial endpoints include safety, tolerability, kidney function, and acute allograft rejection. In March 2024, the Company announced updated data from the first eight patients enrolled in the trial. Today, the Company announced additional data from the trial, including new gene expression data assessing molecular markers of acute rejection, that were presented by Professor Gregory Snell at the ISHLT 2024 Annual Meeting on April 13, 2024. Updated Efficacy: Successful transition of eight of eight patients from oral Tacrolimus to TFF TAC; No evidence of acute rejection: No signs and symptoms suggestive of acute rejection; No use of pulse corticosteroids to treat acute rejection; No deterioration in spirometry suggestive of acute rejection; No chest x-ray findings suggestive of acute rejection; No gene expression evidence of rejection in 4/4 patients with available gene expression data on endobronchial biopsies: Rejection-related genes normalized on TFF TAC in 3/3 patients with abnormal expression of rejection-related genes at baseline while on oral tacrolimus; Rejection-related genes remained normal on TFF TAC in one patient with normal expression of rejection related genes at baseline. 4/4 patients who completed Part A chose to remain on TFF TAC and proceeded to Part B. Updated Safety: No mortality; No TFF TAC discontinuation due to an AE; Majority of TEAEs were Grade 2 or lower in severity; Maintenance of kidney function . Based on these results, TFF Pharmaceuticals plans to open an IND in the US to explore the use of TFF TAC early post-transplant in preparation for a registrational trial.