TFF Pharma Updates on TFF TAC Phase 2 Lung Transplant Rejection Trial

6 out of 6 Patients Who Completed the 12-Week Treatment Have Chosen to Remain on TFF TAC by Proceeding to the Safety Extension Phase; 1 patient has been treated for over a year and 3 additional patients have been treated for more than 6 months

Variability in Systemic Exposure to Tacrolimus Was Reduced with TFF TAC Which Could Lower Risk of Acute Rejection and Systemic Toxicities

TFF Pharmaceuticals, Inc. (NASDAQ: TFFP), a clinical-stage biopharmaceutical company, has announced an update on their ongoing Phase 2 trial of Tacrolimus Inhalation Powder (TFF TAC) aimed at preventing lung transplant rejection. The company’s patented Thin Film Freezing (TFF) technology is central to this development, allowing for innovative drug products with enhanced delivery and efficacy.

Dr. Harlan Weisman, Chief Executive Officer of TFF Pharmaceuticals, expressed satisfaction with the accelerated patient enrollment, attributing it to positive feedback from physicians based on emerging data. “We have now enrolled 10 patients in the TFF TAC Phase 2 study,” he said, hinting at a more detailed clinical update to be provided later in the year.

The Phase 2 trial has seen encouraging participation, with all 6 patients who completed the 12-week treatment period opting to continue with TFF TAC in the safety extension phase. Among these patients, one has been on the treatment for over a year, and three others have been treated for more than six months.

Initial pharmacokinetic (PK) data from the first cohort of patients indicate that TFF TAC results in reduced systemic variability of tacrolimus. The fluctuations in tacrolimus levels commonly seen with oral administration are not present with TFF TAC. This reduction in variability is expected to lower the risks of acute rejection and systemic toxicities, such as chronic kidney disease.

Patients on TFF TAC have reported anecdotal improvements, including fewer headaches, better overall wellness, and easier administration. Dr. Zamaneh Mikhak, Chief Medical Officer, underscored the positive feedback, noting that the inhalation device’s ease of use likely contributes to improved patient compliance. “Initial PK data suggest that TFF TAC’s more targeted delivery results in less variability in systemic tacrolimus levels. This precision has the potential to reduce acute rejection and kidney toxicity,” Dr. Mikhak explained.

TFF Pharmaceuticals’ Thin Film Freezing (TFF) technology transforms various compounds into dry powder formulations with superior characteristics. This process is designed to create dry powder particles suitable for multiple routes of administration, including inhalation, nasal, oral, and topical. The technology enhances bioavailability, speeds up the onset of action, and improves safety and efficacy by enabling direct delivery to target organs, such as the lungs. This targeted delivery often allows for lower doses compared to oral drugs, thereby reducing unwanted side effects.

The TFF process is particularly advantageous because it does not involve heat or stress that could damage complex therapeutic components like fragile biologics. Instead, it reformulates these materials into stable dry powders, making them easier to store and distribute globally.

TFF Pharmaceuticals continues to leverage its TFF platform to convert a wide range of drugs into highly effective dry powder formulations. The technology’s versatility extends to vaccines, small and large molecules, and biologics, making it a pivotal innovation in the pharmaceutical industry. The TFF platform not only promises enhanced delivery methods but also aims to create next-generation pharmaceutical products with improved patient outcomes.

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