TFF Pharmaceuticals Updates on Tacrolimus Inhalation Powder for Preventing Lung Transplant Rejection

TFF Pharmaceuticals, Inc. (NASDAQ: TFFP), a clinical-stage biopharmaceutical company based in Fort Worth, Texas, has provided an important update on its TFF TAC clinical program. This program is centered around TFF TAC, an innovative inhaled dry powder formulation of tacrolimus, a potent immunosuppressive drug. The update follows a recent interaction with the U.S. Food and Drug Administration (FDA), where TFF Pharmaceuticals received constructive feedback to help guide the next stages of clinical development.

In April 2024, TFF Pharmaceuticals submitted a comprehensive briefing book to the FDA. The purpose of this document was to assist in navigating the clinical development pathway for TFF TAC. After reviewing the briefing book, the FDA acknowledged that mitigating or preventing tacrolimus-associated toxicities without compromising the lung allograft is a significant therapeutic benefit. The FDA provided valuable guidance and feedback, which clarified the roadmap for advancing TFF TAC. Importantly, TFF Pharmaceuticals does not anticipate major changes in timelines or estimated costs for the clinical progression of TFF TAC based on the FDA's feedback.

Dr. Zamaneh Mikhak, Chief Medical Officer of TFF Pharmaceuticals, expressed satisfaction with the FDA’s initial feedback. Dr. Mikhak noted that this feedback has clarified how the company can continue to advance TFF TAC towards registrational testing. The company expects to receive more guidance from the FDA in the coming weeks, which will enable a more detailed regulatory update in the third quarter of 2024.

TFF TAC represents a significant advancement in the treatment of lung transplant patients, offering a dry powder formulation of tacrolimus. Tacrolimus, a powerful immunosuppressive medication, is typically administered orally and is the primary calcineurin inhibitor used to prevent rejection after solid organ transplantation. However, oral tacrolimus is associated with several toxicities, particularly kidney toxicity, which is exacerbated when high doses are required after lung transplantation.

The TFF TAC formulation targets the lungs directly, delivering tacrolimus with improved lung immunosuppression at lower doses and systemic exposure compared to oral administration. This approach aims to enhance efficacy while reducing systemic toxicities such as kidney damage. TFF TAC is administered via a user-friendly dry powder inhaler.

The current Phase 2 trial of TFF TAC is an open-label study involving lung transplant patients who need lower tacrolimus blood levels due to kidney toxicity. The trial consists of two parts: Part A, a 12-week treatment period, and Part B, an optional safety extension period. The primary endpoints of the trial include safety and tolerability, focusing on kidney function, acute allograft rejection, and pharmacokinetics.

TFF Pharmaceuticals’ proprietary Thin Film Freezing (TFF) technology underpins TFF TAC. This technology transforms existing compounds and new chemical entities into dry powder formulations with unique characteristics and benefits. The TFF process creates dry powder particles with properties advantageous for various routes of administration, including inhalation, parenteral, nasal, oral, topical, and ocular. This method allows for direct delivery to the target organ, improving bioavailability, onset of action, safety, and efficacy. TFF technology reduces the systemic administration challenges and enhances traditional drug delivery methods, making complex therapeutic components, such as biologics, more accessible and stable.

TFF Pharmaceuticals is dedicated to leveraging its TFF technology platform to develop and commercialize effective drug products. The company's innovative approach has broad applicability, converting a wide range of drugs, including vaccines and biologics, into potent, stable dry powder formulations suitable for various delivery methods. This strategy aims to improve drug efficacy, safety, and stability, ultimately benefiting patients worldwide.