TFF Pharmaceuticals Announces Additional Positive Data from the Tacrolimus Inhalation Powder (TFF TAC) Phase 2 Trial Following Oral Presentation at the ISHLT 44th Annual Late Breaking Clinical Science Abstract Sessions - Seite 2

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 (N=8) 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 highly encouraging 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.

ABOUT TFF PHARMACEUTICALS’ THIN FILM FREEZING (TFF) TECHNOLOGY

TFF Pharmaceuticals’ proprietary Thin Film Freezing (TFF) technology allows for the transformation of both existing compounds and new chemical entities into dry powder formulations exhibiting unique characteristics and benefits. The TFF process is a particle engineering process designed to generate dry powder particles with advantageous properties for inhalation, as well as parenteral, nasal, oral, topical and ocular routes of administration. The process can be used to engineer powders for direct delivery to the site of need, circumventing challenges of systemic administration and leading to improved bioavailability, faster onset of action, and improved safety and efficacy. The ability to deliver therapies directly to the target organ, such as the lung, allows TFF powders to be administered at lower doses compared to oral drugs, reducing unwanted toxicities and side effects. Laboratory data suggests the aerodynamic properties of the powders created by TFF can deliver as much as 75% of the dose to the deep lung. TFF does not introduce heat, shear stress, or other forces that can damage more complex therapeutic components, such as fragile biologics, and instead enables the reformulation of these materials into easily stored and temperature-stable dry powders, making therapeutics and vaccines more accessible for distribution worldwide. The advantages of TFF can be used to enhance traditional delivery or combined to enable next-generation pharmaceutical products.