TFF Pharmaceuticals Makes Available Phase 2 Data from Tacrolimus Inhalation Powder (TFF TAC) for the Prevention of Lung Transplant Rejection Presented at the Recent ISHLT Annual Meeting

Data Now Available on Company Website Following 8-K Filing

Data Demonstrate that Treatment with TFF TAC Prevents Lung Transplant Rejection at Only One-sixth of the Dose of Oral Tacrolimus and at Two-thirds of the Oral Tacrolimus Systemic Trough Exposures

Gene Expression Biomarker Data Demonstrate that Treatment with TFF TAC Leads to Normalization of Expression of Rejection-Related Genes

FORT WORTH, Texas, April 29, 2024 (GLOBE NEWSWIRE) -- TFF Pharmaceuticals, Inc. (NASDAQ: TFFP) (“the Company”), a clinical-stage biopharmaceutical company focused on developing and commercializing innovative drug products based on its patented Thin Film Freezing (TFF) technology platform, today announced that data from the Company’s ongoing Phase 2 trial of Tacrolimus Inhalation Powder (TFF TAC) for the prevention of lung transplant rejection is available on the Company’s website. These data were recently presented by Professor Gregory Snell, the lead Principal Investigator of the TFF TAC Phase 2 study, via an oral presentation at the International Society for Heart and Lung Transplantation (ISHLT) 44th Annual Meeting during a late breaking clinical science abstract session on April 13, 2024. The data became available following the Company’s 8-K filing.

“Following the presentation of these updated data from our ongoing Phase 2 study of TFF TAC at this year’s ISHLT meeting, we have received highly positive feedback from the transplant medicine community, indicating heightened awareness of this innovative program and a growing enthusiasm for its potential to improve upon the current standard of care,” said Harlan Weisman, Chief Executive Officer of TFF Pharmaceuticals. “Looking ahead, we are focused on advancing this highly innovative program into potentially registrational testing, and we look forward to sharing additional data from the TFF TAC Phase 2 trial later this year.”

“These unprecedented results from our Phase 2 study provide evidence that TFF TAC has the potential to optimize lung immune suppression at decreased systemic exposures. TFF TAC can prevent rejection of the transplanted lung when delivered at only one-sixth of the oral tacrolimus dose and at two-thirds of the oral tacrolimus systemic trough exposures, levels predicted to decrease systemic toxicities,” said Dr. Zamaneh Mikhak, Chief Medical Officer of TFF Pharmaceuticals. “In addition, our gene expression data demonstrate that TFF TAC normalizes the expression of genes associated with lung transplant rejection in patients whose systemic exposures are decreased, providing evidence at a molecular level that treatment with TFF TAC can increase lung immune suppression at reduced systemic exposures. These data collectively point to the potential opportunity to improve efficacy as well as safety after lung transplantation with TFF TAC.”