TFF Pharmaceuticals Announces Interim Data From Phase 2 Study of Tacrolimus Inhalation Powder

TFF Pharmaceuticals, Inc. recently announced the acceptance of its late-breaking clinical science abstract for oral presentation at the 44th Annual International Society for Heart and Lung Transplantation (ISHLT) 2024 Meeting, which will be held in Prague, Czech Republic from April 10-13, 2024. On January 9, 2024, the company announced that the data from TFF TAC Phase 2 study was accepted as a late-breaking abstract.

“Results from the ongoing Phase 2 trial of TFF TAC continue to suggest that targeted, inhalational delivery of tacrolimus has the potential to provide sufficient immunosuppression to avoid acute rejection at diminished systemic exposures compared to oral tacrolimus” said Professor Gregory Snell, Medical Head of Lung Transplant Service at the Alfred Hospital and Lead Principal Investigator of the Phase 2 TFF TAC trial. “Based on interim clinical data, TFF TAC appears to have the potential to provide a meaningful advancement in the delivery of immunosuppression therapy, and I look forward to presenting updated data from the Phase 2 trial at the upcoming 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. On March 20, 2024, the Company announced plans to prioritize the clinical development of TFF TAC based on positive Phase 2 data, the potential to address a significant unmet need in lung transplant medicine, and the substantial market opportunity.

TFF Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company engaging patented rapid freezing technology to develop and transform medicines into potent dry powder formulations for better efficacy, safety, and stability. The company’s versatile TFF technology platform has broad applicability to convert most any drug, including vaccines, small and large molecules, and biologics, into an elegant dry powder highly advantageous for inhalation, or for topical delivery to the eyes, nose, and the skin.