FORT WORTH, Texas - TFF Pharmaceuticals, Inc. (NASDAQ: TFFP), a clinical-stage biopharmaceutical company, today announced positive data from its ongoing Phase 2 study evaluating Tacrolimus Inhalation Powder (TFF TAC) for organ rejection prevention in lung transplant recipients.
The data, presented at the International Society for Heart and Lung Transplantation's annual meeting on April 13, 2024, showed that TFF TAC could prevent rejection with lower doses and systemic exposure compared to oral tacrolimus.
The study's primary endpoints include safety, tolerability, kidney function, and acute allograft rejection. Findings revealed successful transition to TFF TAC in all eight patients, with no evidence of acute rejection or necessity for pulse corticosteroids. Moreover, gene expression analysis on endobronchial biopsies from four patients indicated normalization of rejection-related genes.
Notably, the four patients who completed the initial 12-week treatment phase chose to continue with TFF TAC during the safety extension period. The study reported no mortality, no discontinuation of TFF TAC due to adverse events, and a majority of treatment-emergent adverse events were Grade 2 or lower in severity. Kidney function was maintained throughout the study.
These results support the hypothesis that inhalational delivery of tacrolimus could provide effective immunosuppression while potentially reducing the risk of kidney toxicity due to lower systemic drug levels.
Based on these findings, TFF Pharmaceuticals plans to pursue an Investigational New Drug (IND) application in the United States to explore TFF TAC's use immediately post-transplant, in preparation for a registrational trial.
TFF Pharmaceuticals' Thin Film Freezing (TFF) technology platform underpins the development of TFF TAC. The TFF process creates dry powder particles suitable for various administration routes, including inhalation, with the potential for improved bioavailability, faster onset of action, and reduced side effects.
The company continues to collaborate with various pharmaceutical entities, academic institutions, and government organizations to advance healthcare with its TFF technology, which holds over 170 issued or pending patents globally.
The information in this article is based on a press release statement from TFF Pharmaceuticals.
InvestingPro Insights
In light of TFF Pharmaceuticals' encouraging findings from its Phase 2 study, investors may be closely monitoring the company's financial health and market performance. According to recent data from InvestingPro, TFF Pharmaceuticals has a market capitalization of approximately $9.7 million, reflecting the size of the company in the current market. Despite the positive clinical outcomes, the company's financials reveal some challenges. The most recent data indicates a negative P/E ratio of -0.33, suggesting that the company is not currently profitable.
An InvestingPro Tip that stands out in the context of TFF Pharmaceuticals is the company's cash position relative to its debt. TFF Pharmaceuticals holds more cash than debt on its balance sheet, which could provide some financial stability as it continues its clinical trials and pursues new drug applications. Another relevant InvestingPro Tip is the company's significant cash burn rate, which is an important consideration for investors given that the company is quickly burning through cash. This could impact the company's ability to fund ongoing research and development without seeking additional capital.
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