TFF Pharmaceuticals Announces Interim Data from a Phase 2 Study of Tacrolimus Inhalation Powder (TFF TAC) to Prevent Lung Transplant Rejection at the 44th International Society for Heart and Lung Transplantation (ISHLT) 2024 Annual Meeting

Oral Presentation Presenting Latest Data from a Phase 2 Study Demonstrating Successful Transition of Patients from Oral Tacrolimus to TFF TAC

FORT WORTH, Texas, March 25, 2024 (GLOBE NEWSWIRE) — TFF Pharmaceuticals, Inc. (NASDAQ: TFFP) is committed to developing and commercializing innovative medicines based on patented thin film freezing (TFF). A focused clinical stage biopharmaceutical company. The technology platform today announced the acceptance of the latest Clinical Scientific Abstracts for oral presentation at the 44th International Conference.^th The International Society for Heart and Lung Transplantation (ISHLT) 2024 Annual Meeting will be held in Prague, Czech Republic from April 10 to 13, 2024. On January 9, 2024, the company accepted data from the TFF TAC Phase 2 study as an updated abstract.

“Results from an ongoing Phase 2 study of TFF TAC show that targeted inhalation delivery of tacrolimus provides sufficient immunosuppression to avoid acute rejection despite reducing systemic exposure compared to oral tacrolimus.” “The evidence continues to suggest that this is possible,” said Professor Gregory Snell, Director of Pulmonary Medicine. Alfred Hospital Transplant Service and principal investigator of the Phase 2 TFF TAC trial. “Based on interim clinical data, TFF TAC appears to have the potential to provide meaningful advances in the delivery of immunosuppressive therapy, and he will present updated data from phase 2 trials at the upcoming ISHLT 2024 meeting.” I’m looking forward to it.”

Presentation details:

About TFF TAC
The ongoing Phase 2 study of TFF TAC is an open-label study in lung transplant patients who require lower blood levels of tacrolimus due to renal toxicity. Part A of the trial is his 12-week treatment period, and Part B is an optional safety extension period. Study endpoints include safety/tolerability, renal function, and acute allograft rejection. On March 20, 2024, the Company will prioritize clinical development of TFF TAC based on favorable Phase 2 data, potential to address important unmet needs in lung transplant medicine, and significant market opportunity. The plan has been announced.

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About TFF Pharmaceuticals
TFF Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company that leverages patented deep-freezing technology to develop and transform pharmaceutical products into potent dry powder formulations that improve efficacy, safety, and stability. To do. The company’s versatile TFF technology platform converts most drugs, including vaccines, small and large molecules, and biologics, into elegant dry powders that are highly advantageous for inhalation and topical delivery to the eyes, nose, and skin. It has a wide range of applicability.

safe harbor
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 regarding the potential benefits of our TFF TAC and our TFF platform. Because the offering is subject to market and other conditions, there can be no assurance as to whether or when the offering will be completed. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results to differ materially. These include (i) the risk that further data from the ongoing Phase 2 clinical trial of TFF TAC will not be in good agreement with plans; initial data readout; (ii) the risk that the Company may not proceed to the study that would enable enrollment of his TFF TAC; and (iii) success in the early stages of the clinical trial may affect the success of subsequent clinical trials. There is no guarantee. (iv) any drug product incorporating the TFF platform has not received FDA premarket approval or been incorporated into a commercially available drug product; (v) We do not currently have any agreements or understandings with major pharmaceutical companies regarding the development of pharmaceutical products. By incorporating the TFF platform, there is a risk that the Company will not be able to obtain additional working capital to continue the Phase 2 clinical trial of his TFF TAC or proceed to initiate trials that would enable registration of the TFF TAC. risk of not being able to do so. (vii) other risks described in the “Risk Factors” section included in the Company’s Quarterly Report on Form 10-Q filed with the SEC on November 14, 2023; We caution readers not to place undue reliance on the information below. Forward-Looking Statements. We undertake no obligation, and specifically disclaim any obligation, to update or revise such statements in the event of new circumstances or unforeseen events, except as required by law.

Investor relationship contact:
Dr. Corey Davis
Life science advisor
(212) 915-2577
cdavis@lifesciadvisors.com

Source: TFF Pharma Co., Ltd.