TFF Pharmaceuticals Reports Positive Phase 2 Results for Tacrolimus Inhalation Powder in Preventing Lung Transplant Rejection

TFF Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company, has announced significant progress in its ongoing Phase 2 trial of Tacrolimus Inhalation Powder (TFF TAC) aimed at preventing lung transplant rejection. The company, which leverages its proprietary Thin Film Freezing (TFF) technology to develop innovative drug formulations, provided an update reflecting the promising outcomes from the trial.

Dr. Harlan Weisman, CEO of TFF Pharmaceuticals, expressed optimism about the TFF TAC Phase 2 study, noting the transformative potential of TFF TAC in enhancing immunosuppressive therapy for lung transplant patients. He mentioned that the company is in the final stages of designing the next study phase, collaborating closely with clinical investigators and regulatory authorities.

Enrollment in the Phase 2 trial has accelerated, with a total of 13 patients now participating. TFF TAC, administered at approximately 20% of the oral tacrolimus dosage, has successfully prevented acute rejection while maintaining over 80% of the previous oral blood levels, thus decreasing the drug burden on patients. This outcome is significant as it suggests that TFF TAC can offer effective immunosuppression with a lower dose compared to oral administration.

Remarkably, the study reported no signs or symptoms indicative of acute rejection among participants. Patients did not require pulse corticosteroids, nor did they show any spirometry deterioration, chest x-ray abnormalities, or biomarker evidence pointing to acute rejection. Additionally, TFF TAC did not trigger the production of donor-specific antibodies (DSA), which are typically associated with antibody-mediated rejection.

Out of the 9 patients who completed the 12-week treatment period, all opted to continue with TFF TAC in the long-term extension phase. Among these, 2 patients have been on the treatment for over a year, while 6 have been treated for more than 6 months, bringing the total patient exposure to 2,063 days.

Pharmacokinetic (PK) data from the trial indicates that TFF TAC results in reduced systemic variability of tacrolimus, avoiding the peak and trough concentration swings seen with oral tacrolimus. This steadier concentration is expected to lower the risk of organ rejection and systemic toxicities, such as chronic kidney disease.

Updated biomarker data demonstrated a 6.5-fold reduction in the number of abnormally expressed rejection-related gene sets after 12 weeks of TFF TAC treatment. This significant decrease suggests that TFF TAC provides adequate immunosuppression to prevent rejection. Additionally, new data on the presence of DSA in the first 8 patients showed no production of these antibodies after transitioning from oral tacrolimus to TFF TAC, indicating effective systemic immune suppression.

The trial also showed that TFF TAC was well-tolerated among participants, with no recorded mortality and most adverse events being moderate or lower in severity. No instances of bronchospasm or wheezing were reported, and kidney function remained stable.

A single patient was transitioned to a dose of TFF TAC that was too low, resulting in blood trough levels falling below the protocol-specified minimum. This led to mild acute rejection symptoms, but TFF TAC was discontinued, and the patient returned to oral tacrolimus, resolving the episode.

Dr. Zamaneh Mikhak, Chief Medical Officer of TFF Pharmaceuticals, highlighted the positive emerging product profile of TFF TAC, emphasizing the importance of the new DSA and gene expression data. The absence of DSA formation and the significant reduction in rejection-related gene expression underscore TFF TAC's potential to maintain sufficient immunosuppression.

TFF Pharmaceuticals' proprietary TFF technology is a particle engineering process that transforms both existing compounds and new chemical entities into dry powder formulations. This process is beneficial for various routes of administration, including inhalation, and is designed to improve bioavailability, onset of action, and overall drug safety and efficacy. The technology is particularly advantageous for delivering therapies directly to target organs, such as the lungs, at lower doses, thereby reducing unwanted toxicities and side effects.

Overall, TFF Pharmaceuticals is advancing towards the next phase of its TFF TAC study, with plans to provide further updates, including regulatory advancements, later in the year.

How to obtain the latest research advancements in the field of biopharmaceuticals?

In the Synapse database, you can keep abreast of the latest research and development advances in drugs, targets, indications, organizations, etc., anywhere and anytime, on a daily or weekly basis. Click on the image below to embark on a brand new journey of drug discovery!