TFF Pharma Reports Positive Tacrolimus Inhalation Powder Phase 2 Results at ISHLT Meeting

TFF Pharmaceuticals is revolutionizing the pharmaceutical industry with their innovative Thin Film Freezing (TFF) technology. This unique process transforms medicines into dry powders, enhancing their efficacy, safety, and stability. The company's initial focus is on lung-directed drugs, capitalizing on their expertise in respiratory medicine and the platform's ability to improve outcomes across various therapeutic areas.

The TFF technology allows for the conversion of a wide range of drugs, including vaccines, small and large molecules, and biologics, into dry powders. These powders are advantageous for inhalation and topical delivery to the eyes, nose, and skin. The TFF process is a particle engineering technique that generates dry powder particles with properties conducive to direct delivery to the site of need, bypassing systemic administration challenges and leading to improved bioavailability and faster onset of action.

One of the key benefits of TFF technology is its ability to administer therapies directly to the target organ, such as the lung, at lower doses compared to oral drugs. This reduction in dosage minimizes unwanted toxicities and side effects. Laboratory data indicates that the aerodynamic properties of TFF-created powders can deliver up to 75% of the dose to the deep lung. The TFF process does not introduce heat, shear stress, or other forces that can damage fragile therapeutic components, such as biologics. Instead, it reformulates these materials into easily stored and temperature-stable dry powders, making therapeutics and vaccines more accessible for global distribution.

TFF Pharmaceuticals has two lead drug candidates in clinical trials: TFF TAC (Tacrolimus Inhalation Powder) and TFF VORI (Voriconazole Inhalation Powder). The company is committed to collaborating with pharmaceutical companies, academic institutions, and government partners to revolutionize healthcare globally. The TFF platform is protected by over 170 patents issued or pending in the U.S. and internationally.

The TFF technology offers a promising future for drug delivery, with the potential to optimize lung immune suppression while decreasing systemic exposures and toxicities. The company's ongoing Phase 2 trial of TFF TAC is an open-label study in lung transplant patients requiring reduced tacrolimus blood levels due to kidney toxicity. The trial has shown successful transitions from oral Tacrolimus to TFF TAC, with no evidence of acute rejection and maintenance of kidney function.

TFF Pharmaceuticals is poised to advance TFF TAC into potentially registration-enabling studies, building on the encouraging results from the Phase 2 clinical trial. The company's commitment to innovation and collaboration is set to transform the way medicines are developed and delivered, ultimately improving health outcomes worldwide.