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

Oral Presentation to Present Updated Data from Phase 2 Trial Demonstrating Successful Transition of Patients from Oral Tacrolimus to TFF TAC

March 25, 2024 09:01 ET

FORT WORTH, Texas, March 25, 2024 (GLOBE NEWSWIRE) — TFF Pharmaceuticals, Inc. (NASDAQ: TFFP), 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 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.”

Presentation Details:

Control Number: 5349
Abstract Title: Multicenter Open-Label Tacrolimus Inhalation Powder Trial Evaluating Safety, Tolerability, Efficacy and Pharmacokinetics (pk) in Lung Transplant (ltx) 
Recipients with Significant Renal Impairment
Presenter: Professor Gregory Snell
Session: ORAL SESS 39
Date/Time: Saturday, April 13, 2024, 8:00 – 9:15 AM CEST

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.

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 regarding the potential advantages of our TFF TAC and our TFF platform. The offering is subject to market and other conditions and there can be no assurance as to whether or when the offering may be completed.  Forward-looking statements involve known and unknown risks, uncertainties and other factors that could cause actual results to differ materially, including (i) the risk that the further data from the ongoing Phase 2 clinical trial of TFF TAC will not be favorably consistent with the initial data readouts, (ii) the risk that the Company may not be able to advance to registration-enabling studies for TFF TAC, (iii) success in early phases of clinicals trials do not ensure later clinical trials will be successful; (iv) no drug product incorporating the TFF platform has received FDA pre-market approval or otherwise been incorporated into a commercial drug product, (v) the Company has no current agreements or understandings with any large pharmaceutical companies for the development of a drug product incorporating the TFF Platform, (vi) the risk that the Company may not be able to obtain additional working capital with which to continue the Phase 2 clinical trial for TFF TAC, or advance to the initiation of registration-enabling studies, for TFF TAC as and when needed and (vii) those other risks disclosed in the section “Risk Factors” included in the Company’s Quarterly Report on Form 10-Q filed with the SEC on November 14, 2023. The Company cautions readers not to place undue reliance on any forward-looking statements. The Company does not undertake and specifically disclaims any obligation to update or revise such statements to reflect new circumstances or unanticipated events as they occur, except as required by law.

Investor Relations Contact:
Corey Davis, Ph.D.
LifeSci Advisors
(212) 915-2577

Source: TFF Pharmaceuticals, Inc.